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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    
Materials:
   
       

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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 OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

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Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

Meeting Date: 9/9/14-9/9/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/10/14-9/10/14

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Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Methodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

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Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 9/11/14-9/11/14

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (NPS Pharma)

Meeting Date: 9/12/14-9/12/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Bone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

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Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| FDA’s GDUFA Public Hearing on Policy Development

Meeting Date: 9/17/14-9/17/14

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Meeting Details:

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

 

       
Location: College Park Marriott Hotel and Conference Center 3501 University Boulevard East Hyattsville, MD 20783 Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Pediatric AdComm

Meeting Date: 9/23/14-9/23/14

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Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Gastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

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Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

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Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

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

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Past Meetings

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

Live Meetings

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