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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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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    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/14/15-4/14/15

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Meeting Details:

During the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB. During the afternoon session, the committee will discuss the results of the CVOT, Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care, for NDA 22271, Nesina (alogliptin); NDA 022426, Oseni (alogliptin and pioglitazone); and NDA 203414, Kazano (alogliptin and metformin) tablets marketed by Takeda Pharmaceutical U.S.A., Inc. Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP4) inhibitors, both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Both CVOTs were submitted in accordance with the 2008 FDA Draft Guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 7:30AM-5:15AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 4/15/15-4/15/15

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Meeting Details:

The committee will discuss new drug application New Drug Application 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 4/17/15-4/17/15

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Meeting Details:

On April 17, 2015, the committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology. FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies, for flow diverter technology indicated for the neurovasculature.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies and ODAC

Meeting Date: 4/29/15-4/29/15

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Meeting Details:

The committees will discuss talimogene laherparepvec, Amgen, Inc., biologics license application (BLA) 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 4/30/15-5/1/15

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Meeting Details:

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Insert),” Product Code EWD, as unclassified under the 510(k) premarket notification authority. Circumaural Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Circumaural),” Product Code EWE, as unclassified under the 510(k) premarket notification authority. Middle Ear Inflation Devices are currently regulated under the heading, “Device, Inflation, Middle Ear,” Product Code MJV, as unclassified under the 510k) premarket notification authority. Tactile Hearing Aid Devices are currently regulated under the heading, “Hearing Aid, Tactile,” Product Code LRA, as unclassified under the 510(k) premarket notification authority. Vestibular Analysis Apparatuses are currently regulated under the heading, “Apparatus, Vestibular Analysis,” Product Code LXV, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the risks, safety and effectiveness and the regulatory classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. These issues are categorized into three broad areas for discussion: 1. Cochlear implant changes (e.g. sound processing features, patient characteristics) that may be suitable for this pre- to post-market shift in clinical data requirements. 2. Appropriate premarket clinical data requirements to support pre- to post-market shift (e.g. leveraging clinical data from adults and/or older children.) 3. Clinical study design considerations (e.g. study endpoints and test metrics, subject characteristics) for post market studies to confirm safety and effectiveness and inform future labeling.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 3/24/15-3/24/15

Meeting Details:

On March 24, 2015, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). The PAC will meet to discuss the following products: CYMBALTA (duloxetine hydrochloride), QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO (sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol), DYMISTA (azelastine hydrochloride/fluticasone proprionate), QNASL (beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE (saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT (influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza virus vaccine), Medtronic ACTIVA DYSTONIA THERAPY, and LIPOSORBER LA-15 System. In addition, there will be a short presentation of the ethical issues discussed by the Pediatric Ethics Subcommittee of the PAC on March 23, 2015.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee of the Pediatric AdComm

Meeting Date: 3/23/15-3/23/15

Meeting Details:

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. A brief summary of the subcommittee's discussion will then be presented to the FDA Pediatric Advisory Committee on Tuesday, March 24, 2015.

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/19/15-3/19/15

Meeting Details:

The committees will discuss supplemental new drug application 204275-S001, for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age and older. The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Anesthetic and Analgesic Drug AdComm

Meeting Date: 3/18/15-3/18/15

Meeting Details:

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPostPoned: Arthritis AdComm

Meeting Date: 3/17/15-3/17/15

Meeting Details:

The committee will discuss biologics license application (BLA) 125544 for CTP13, 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 Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 3/9/15-3/9/15

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/4/15-3/4/15

Meeting Details:

On March 4, 2015, from 8:30 a.m. to 3 p.m., 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 2015-2016 influenza season.

 

       
Location: Hilton - Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/27/15-2/27/15

Meeting Details:

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows: The Radiesse device is for hand augmentation to correct volume deficit in the hands. FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

 

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

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Past Meetings

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