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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsAntimicrobial Drugs AdComm

Meeting Date: 4/25/19-4/26/19

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Meeting Details:

Day 1 - On April 25th, The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. Day 2 - On April 26th, The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 5/7/19-5/7/19

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Meeting Details:

The committee will discuss the following topics: (1) Approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of `exposure-matching' under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of `exposure matching,' including the necessary assumptions and any limitations.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/8/19-5/8/19

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Meeting Details:

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

 

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

Meeting Date: 5/14/19-5/14/19

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Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 211810 for pexidartinib capsule, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, also referred to as giant cell tumor of the tendon sheath or pigmented villonodular synovitis, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery. During the afternoon session, the committee will discuss NDA 212166 for quizartinib tablets, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory acute myeloid leukemia, which is FLT3-ITD positive, as detected by an FDA-approved test.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 4/8/19-4/8/19

Meeting Details:

On April 8, 2019, the PAC will meet to discuss drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies ("classic hypogonadism"). The following topics will be considered for discussion: diagnosing male adolescents with classic hypogonadism, evidence to establish efficacy and safety of testosterone replacement therapy in this population, study design, and feasibility considerations for such studies. The committee will not discuss any individual research programs.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Pulmonary-Allergy Drugs AdComm

Meeting Date: 3/27/19-3/27/19

Meeting Details:

The committee will discuss new drug application (NDA) 208646, submitted by AllerQuest, LLC, for a skin-test kit (proposed trade name PRE-PEN Plus) that combines the approved product PRE-PEN (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic acid, and amoxicillin sodium, for the proposed indication to detect IgE sensitization to penicillin antigens and reliably rule out the potential for immediate life- threatening penicillin allergic reactions with a high degree of probability in patients with history of possible IgE-dependent penicillin allergy. The discussion will include study design considerations, the contribution of each of the components, and whether the submitted data provide substantial evidence of efficacy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/19-3/26/19

Meeting Details:

On March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/21/19-3/21/19

Meeting Details:

On March 21, 2019, the committee will discuss and make recommendations on clinical information related to the de novo request for the NeuroAD Therapy System by Neuronix, Ltd. The NeuroAD Therapy System is intended to provide concurrent neurostimulation and cognitive training for the treatment of mild to moderate Alzheimer's dementia.

 

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

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