FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED - Cellular, Tissue and Gene Therapies AdComm

Meeting Date: 10/22/13-10/23/13

Meeting Details:

On October 22 from 8 a.m. to 5:30 p.m. and on October 23 from 8 a.m. to approximately 11:15 a.m. the Committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. On October 23 from approximately 11:15 a.m. to 11:30 a.m. the Committee will hear updates on guidance documents issued from the Office of Cellular Tissue and Gene Therapies Center for Biologics Evaluation and Research (CBER) FDA. On October 23 from 12:30 p.m. to approximately 5 p.m. the Committee will discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiosimilar and Interchangeable Biological Products Public Meeting

Meeting Date: 11/2/10-11/3/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies AdComm - Call for LIVE Service

Meeting Date: 10/9/09-10/9/09

Meeting Details:

*** Call for LIVE Service Option *** 301.984.0001 On October 9, 2009, in open session, the Committee will discuss ISOLAGEN THERAPY, BLA 125348, Isolagen Technologies, Inc., for moderate to severe nasolabial fold wrinkles. Nasolabial fold wrinkles are the two skin folds that run from each side of the nose to the corners of the mouth.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies AdComm

Meeting Date: 5/14/09-5/15/09

Meeting Details:

On May 14 in the morning, in open session, the Committee will discuss the potential for Chlamydia trachomatis and Neisseria gonorrhea transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system or gestational tissues (e.g., amnionic membrane and placenta, cells recovered from menstrual blood, foreskin, placental/umbilical cord blood derived cell products), or other sources. In the afternoon, in open session, the Committee will discuss animal models for porcine xenotransplantation products intended to treat Type 1 diabetes or acute liver failure. On May 15, in open session, the Committee will: (1) Receive an update on Guidance documents from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research and the Center for Veterinary Medicine and (2) discuss clinical issues related to the FDA draft guidance Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies

Meeting Date: 4/10/08-4/11/08

Meeting Details:

On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On April 11, 2008, the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies Advisory Committee

Meeting Date: 3/29/07-3/30/07

Meeting Details:

On March 29, 2007, in open session, the committee will discuss Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the treatment of men with asymptomatic metastatic hormone refractory prostate cancer. The committee will also hear overviews of research programs in the Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research. On March 30, 2007, in open session, the committee will discuss the draft document entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies.'' For a copy of the draft guidance visit http://www.fda.gov/cber/gdlns/cordbld.pdf. The committee will also discuss scientific issues regarding minimally manipulated, unrelated allogeneic peripheral blood stem cells. On March 29, 2007, in open session, the committee will discuss Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the treatment of men with asymptomatic metastatic hormone refractory prostate cancer. The committee will also hear overviews of research programs in the Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research. On March 30, 2007, in open session, the committee will discuss the draft document entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies.'' For a copy of the draft guidance visit http://www.fda.gov/cber/gdlns/cordbld.pdf. The committee will also discuss scientific issues regarding minimally manipulated, unrelated allogeneic peripheral blood stem cells.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies Advisory Committee

Meeting Date: 3/3/05-3/4/05

Meeting Details:

On March 3-4, 2005 the Committee will discuss cellular therapies for repair and regeneration of joint surfaces. The Committee will also receive the following updates: 1) on March 3, 2005, in the afternoon, updates of research programs in the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research; 2) on March 4, 2005, in the morning, update on the FDA Critical Path Initiative.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 3/18/04-3/19/04

Meeting Details:

On March 18 and 19, 2004, the committee will discuss issues related to the design of early phase clinical trials of cellular therapies for the treatment of cardiac diseases.

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 10/9/03-10/10/03

Meeting Details:

On October 9-10, 2003, the committee will 1) discuss issues related to manufacturing data and clinical evidence to be provided in a biologics license application (BLA) for marketing approval of allogeneic islet transplantation to treat type 1 diabetes mellitus; 2) hear updates of individual research programs in the Office of Cellular, Tissue and Gene Therapies; and 3) discuss reports of internal research programs in the Office of Cellular, Tissue and Gene Therapies.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 2/27/03-2/28/03

Meeting Details:

On February 27, 2003 from 8:00 a.m. to approximately 3:45 p.m. the committee will discuss efficacy data for the use of minimally manipulated hematopoietic stem cells from placental/umbilical cord blood for hematopoietic reconstitution for particular age groups. From approximately 3:45 to 5:30 p.m. the committtee will receive updates of research programs in the Division of Monoclonal Antibodies. On February 28, 2003 from 8:00 a.m. to approximately 4:30 p.m. the committee will discuss safety issues related to the use of retrovirus vectors in gene therapy clinical trials.

 

       
Location: Holiday Inn Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 10/10/02-10/10/02

Meeting Details:

The committee will discuss safety issues recently identified related to retrovirus vectors in gene therapies for the treatment of patients with severe combined immune deficiency disease and receive updates on individual research programs in the Division of Cell and Gene Therapies and the Division of Therapeutic Proteins.

 

       
Location: Hilton Hotel GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 5/9/02-5/10/02

Meeting Details:

On May 9, 2002, at 8:00 a.m. the committee receives updates of research programs in the Division of Therapeutic Proteins and the Division of Monoclonal Antibodies, at 9:00 a.m. the committee discusses issues related to ooplasm transfer in assisted reproduction. On May 10, 2002, the committee discusses issues related to inadvertent germline transmission of gene transfer vectors.

 

       
Location: Hilton Hotel Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 10/24/01-10/26/01

Meeting Details:

On October 24, 2001, the committee will meeting to discuss long-term follow-up of participants in gene transfer clinical trials. On October 25, 2001, the committee will discuss vector design, manufacture, and preclinical studies of lentivirus vectors in gene transfer clinical trials. On October 26, 2001, the committee will discuss development of a lentivirus vector gene transfer product for people with HIV.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiologic Response Modifiers Advisory Committee

Meeting Date: 7/13/01-7/13/01

Meeting Details:

On July 13, 2001, the committee will meet to 1)to discuss responses to the March 6, 2000 FDA Gene Therapy Letter (http://www.fda.gov/cber/ltr/gt030600.htm) related to adenovirus vector titer measurements and replication competent adenovirus levels and, 2) hear an update on the NIH Final Action on Serious Adverse Reporting.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 4/5/01-4/6/01

Meeting Details:

On April 5-6, 2001, the committee will meet to discuss: 1) responses to the March 6, 2000 FDA Gene Therapy Letter (http://www.fda.gov/cber/letters.htm); 2) results of gene therapy clinical site inspections, 3) long-term follow-up of gene therapy patients, and 4) the FDA proposed rule - Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation (http://www.fda.gov/cber/rules.htm). In addition, the committee will receive an update on two research programs in the Division of Cellular and Gene Therapies and the Division of Monoclonal Antibodies, Center for Biologics Evaluation and Research.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 11/16/00-11/17/00

Meeting Details:

On November 16-17, 2000, the Committee will meet to discuss the following issues related to gene therapy clinical trials: 1)product characterization, 2) preclinical models and, 3) long term follow-up.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 7/13/00-7/14/00

Meeting Details:

On July 13 and 14, 2000, the committee will discuss product development issues related to human stem cells as cellular replacement therapies for neurological disorders.

 

       
Location: Hilton Hotel Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 3/20/00-3/21/00

Meeting Details:

On March 20-21, the committee will discuss: 1) issues related to the use of human pancreatic islets for the treatment of diabetes, including product development issues relating to the procurement, processing and characterization of islets, preclinical animal models for islets and a brief clinical perspective; and 2) the report of the January 13, 2000, meeting of the Xenotransplantation Subcommittee. Also, the committee will hear an update of research programs in the Division of Cellular and Gene Therapies and the Division of Therapeutic Proteins.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 1/13/00-1/13/00

Meeting Details:

The Xenotransplantation Subcommittee will discuss the following public health issues concerning xenotransplantation: (1) Update of scientific data concerning porcine endogenous retrovirus, (2) blood donor deferral, and (3) examination of risks posed by different types of xenotransplantation products.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 7/15/99-7/15/99

Meeting Details:

The committee will discuss FDA regulatory policy concerning the implications on biological product development of fast track and the recent pediatric rule, immune reactions to therapeutic and diagnostic biological products and the report of the June 3-4, meeting of the Xenotransplantation Subcommittee. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Bethesda Holiday Inn, 8120 Wisconsin Avenue, Bethe Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 6/3/99-6/4/99

Meeting Details:

On June 3 and 4, 1999, the Xenotransplantation Subcommittee will discuss the following public health issues concerning porcine xenotransplantation: (1) Update of scientific data concerning porcine endogenous retrovirus, (2) update of patient monitoring and screening data concerning patients who have received a porcine xenograft, (3)update on FDA xenotransplantation policy development, and (4)proposals for solid organ xenotransplantation.

 

       
Location: Holiday Inn Versailles Ballrooms I and II 8120 W Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 11/13/98-11/13/98

Meeting Details:

Focus on high risk transplantations. From 8:00 a.m. to 8:30 a.m. the meeting will be closed to the public to discuss industry trade secrets.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 7/30/98-7/30/98

Meeting Details:

During the morning session, the Committee will discuss biologics license application 97-0509, Amgen Inc.'s Stemgenâ (ancestim). An indication is sought, in combination with Neupogenâ (filgrastim), for use in mobilization of peripheral blood progenitor cells. In the afternoon, the Committee will discuss the report from the December 17, 1997 meeting of the Xenotransplantation Subcommittee. The Committee will also discuss the research programs in the Laboratory of Immunology and the Laboratory of Molecular Immunology, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 3/24/98-3/24/98

Meeting Details:

Premarketing Approval Application BP94-001/03, for Ceprate(R) SC System, CellPro Incorporated

 

       
Location: Doubletree Hotel, Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 10/17/97-10/17/97

Meeting Details:

During the morning session, the committee will discuss Zenapax, (dacliximab, a humanized monoclonal antibody directed against the human interleukin 2 receptor), Hoffmann-La Roche. An indication is sought for the prophylaxis of acute organ rejection as part of an immunosuppressive regimen for patients receiving cadaveric kidney transplants. During the afternoon session, the committee will discuss Intron-A, (recombinant human interferon, interferon alfa-2b), Schering-Plough Corp. An indication is sought for the treatment of patients with high-tumor burden, follicular non-Hodgkin's lymphoma, in conjunction with combination chemotherapy.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers Advisory Committee

Meeting Date: 7/24/97-7/25/97

Meeting Details:

On July 24, 1997, during the morning session, the committee will discuss Neumega (oprelvekin, recombinant human interleukin eleven, rhIL-11), Genetics Institute. An indication is sought for Neumega for the prevention of chemotherapy-induced thrombocytopenia and reduction in the need for platelet transfusions in patients with nonmyeloid malignancies. During the afternoon session, the committee will discuss a premarket approval application for a device to concentrate CD34 positive cells in autologous peripheral blood stem cell products used for hematopoietic rescue. General data requirements for cell selection devices for hematopoietic rescue will also be discussed. On July 25, 1997, the committee will discuss Rituximab (C2B8 monoclonal antibody), IDEC. The company is seeking an indication for Rituximab as a treatment for patients with relapsed or refractory low grade or follicular B-cell non-Hodgkin's Lymphoma. The committee will also discuss Neupogen, (Filgrastim, granulocyte colony-stimulating factor), Amgen. An indication is sought for use of Neupogen to reduce the duration of neutropenia, fever, hospitalization, and antibiotic use in patients with acute myeloid leukemia.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 10/21/96-10/21/96

Meeting Details:

The committee will discuss the: (1) FDA oncology initiative; (2) standards for approval of therapies for non- Hodgkin's Lymphoma; and (3) intramural research program for the Laboratory of Cell Biology, Laboratory of Immunobiology, and the Laboratory of Cell and Viral Regulation in the Office of Therapeutics Research and Review of the Center for Biologics Evaluation and Research.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 2/28/96-2/29/96

Meeting Details:

Open committee discussion. On February 28, 1996, the committee will: (1) Discuss premarket approval application (PMA) 94-001, for CEPRATE SC Device (CellPro), for selection of CD34+ progenitor/stem cells, and (2) then receive an update on stem cell policy. On February 29, 1996, the committee will discuss: (1) Clinical trials in in utero stem cell transplantation: Issues in early clinical trial development, and (2) the draft document ``Addendum on Gene Therapy to the 1991 Points to Consider (PTC) on Human Somatic Cell and Gene Therapy.''

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 11/13/95-11/13/95

Meeting Details:

The committee will discuss drugs Leukine and Neupogen for cell mobilization and cancer treatment.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 4/10/95-4/11/95

Meeting Details:

On April 10, 1995, the committee will discuss: (1) Product license application supplement, reference number 94-0381, for Roferon A (Interferon-alpha-2a) Hoffman La Roche Inc., for treatment of chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia; and (2) product license application supplements 94-0291 and 93-0287, for Sargramostim (GM-CSF), Immunex Corp., for acceleration of neutrophil recovery following chemotherapy in acute nonlymphoblastic leukemia and for chemotherapy-induced neutropenia (this discussion will continue on the following morning). On the morning of April 11, 1995, the committee will also discuss perspectives on xenotransplantation. In the afternoon, the committee will discuss the intramural scientific program of the Laboratory of Bone Marrow Growth Factors and research programs of individuals in the Division of Hematologic Products and Division of Cytokine Biology.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBiological Response Modifiers

Meeting Date: 12/8/94-12/8/94

Meeting Details:

N/A

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/18/16-2/18/16

.

Meeting Details:

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/19/16-2/19/16

.

Meeting Details:

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Amended: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 2/25/16-2/26/16

.

Meeting Details:

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for ``TOPAS Treatment for Fecal Incontinence,' by ASTORA Women's Health, LLC. The ``TOPAS Treatment for Fecal Incontinence' device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the ``TOPAS Treatment for Fecal Incontinence' device, as stated in the PMA, is as follows: The ``TOPAS Treatment for Fecal Incontinence' is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows: OTN and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAG and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAH and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;' OTO and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' PAJ and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' OTP and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed' and PAI and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.' Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: Urogynecologic surgical mesh instrumentation is used: [cir] IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code ``LKX' and the associated device classification name, ``Device, Thermal, Hemorrhoids.' The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). [cir] IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. [cir] IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. [cir] IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code ``LRL' and the associated device classification name, ``Cushion, Hemorrhoid.' The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). [cir] IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. [cir] IFU/IU: Intended for the home convalescent patient with perineal discomfort. Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts ``slight' pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code ``LKN' and the associated device classification name, ``Separator, automated, blood cell and plasma, therapeutic.' The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments [[Page 940]] became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. Uses continuous flow access to a rotating centrifuge to separate blood components. [cir] IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. [cir] IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

.

Meeting Details:

On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/15/16-3/16/16

.

Meeting Details:

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length = 24 millimeters (mm)) with a reference vessel diameter of = 2.5 mm and = 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 4/7/16-4/7/16

.

Meeting Details:

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/3/16-2/3/16

Meeting Details:

During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 1/21/16-1/21/16

Meeting Details:

The committees will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

There are no Live Broadcasts available at this time.