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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management

Meeting Date: 11/18/14-11/18/14

Meeting Details:

The committee will discuss the Food and Drug Administration Amendments Act of 2007 which requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before the Drug Safety and Risk Management (DSaRM) Advisory Committee. The Agency plans to discuss the risk management of eculizumab (SOLIRIS). The Agency will seek public input whether the REMS with ETASU for this drug assures safe use of the drug, is not unduly burdensome on patient access to the drug, and to the extent practicable, minimizes the burden on the health care delivery system.

 

       
Location: The Great Room Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management AdComm

Meeting Date: 7/10/13-7/10/13

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of LOTRONEX (alosetron hydrochloride) tablets, by Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 1/24/13-1/25/13

Meeting Details:

On January 24 and 25, 2013, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 12/12/12-12/13/12

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans to present information on the risk management of teratogens, some of which have REMS with ETASU. On December 12, 2012, the DSaRM advisory committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. The discussion will include an evaluation of the different strategies and the decision framework for selecting risk management strategies for teratogens. The committee will discuss whether the risk management strategies, including REMS with ETASU, assure safe use, are not unduly burdensome to patient access to the drug, and to the extent practicable, minimize the burden to the health care delivery system. On December 13, 2012 the committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing. The committee will discuss considerations for standardizing recommendations for use of these two tools.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Drug Safety and Risk Management AdComm

Meeting Date: 10/29/12-10/30/12

Meeting Details:

On October 29 and 30, 2012, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Anesthetic and Life Support Drugs AdComm

Meeting Date: 12/2/10-12/2/10

Meeting Details:

MEETING CANCELLED - On December 2, 2010, the committees will begin with a closed session from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. The committees will discuss new drug application (NDA) 201655, Oxymorphone HCl Extended-Release Tablets, Endo Pharmaceuticals, Inc., and its safety for the proposed indication of relief of moderate to severe pain in patients requiring continuous, aroundthe- clock opioid treatment for an extended period of time. The extended-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxymorphone.

 

       
Location: The Marriott Inn and Conference Center, University of Maryland University College Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management AdComm

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

Meeting Details:

The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.

 

       
Location: The Marriott Inn and Conference Center - Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management AdComm

Meeting Date: 2/1/08-2/1/08

Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 22–054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Incorporated, used for the treatment of iron deficiency anemia in patients with postpartum hemorrhage or heavy uterine bleeding.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management AdComm

Meeting Date: 2/9/06-2/10/06

Meeting Details:

Cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations. The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks. On February 9, 2006, the committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes. On February 10, 2006, the committee will be briefed on developments in the Office of Drug Safety and will receive updates on the Drug Safety Oversight Board and agency actions for the COX-2 selective Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and the risk management program for the isotretinoin products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 5/18/05-5/19/05

Meeting Details:

This is the first in a series of meetings related to the issues in drug safety and FDA. This 2 day meeting will explore issues related to FDA's risk assessment program for marketed drugs. There are a number of methods that FDA uses in risk assessment of marketed drugs, including review and analysis of spontaneous reports of adverse events, drug use data, healthcare administrative data, epidemiologic and observational studies, clinical trials, and active surveillance systems. Considerations will include the advantages and disadvantages of the current system for safety signal detection, and proposals for short-term and long-term ways to improve the current system.

 

       
Location: HOL Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 5/8/17-5/9/17

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Meeting Details:

The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

Meeting Date: 5/10/17-5/10/17

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Meeting Details:

The committee will discuss new drug application (NDA) 208-630 for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices AdComm

Meeting Date: 5/17/17-5/17/17

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Meeting Details:

On May 17, 2017, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TRANSMEDICS ORGAN CARE SYSTEM (OCS)--Lung System, by TransMedics, Inc. The proposed Indication for Use, as stated in the PMA, is as follows: The TRANSMEDICS ORGAN CARE SYSTEM (OCS) Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 5/17/17-5/17/17

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Meeting Details:

On May 17, 2017, the VRBPAC will meet in an open session to discuss considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Pediatric AdComm and the Pediatric Ethics Subcommittee

Meeting Date: 5/18/17-5/18/17

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Meeting Details:

On May 18, 2017, the PAC and the PES will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.” Comments about the upcoming joint meeting should be submitted to Docket No. FDA 2017-N-1780.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/24/17-5/25/17

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Meeting Details:

On May 24th during the morning session, the committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication (use) for this product is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy. During the afternoon session, the committee will discuss NDA 208587, for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication (use) for this product is for the treatment of sickle cell disease. On May 25th the committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications/uses for this product are: (1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at = 4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of = 500 m units/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to <13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 4/13/17-4/13/17

Meeting Details:

The committee will discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections; examples of such drugs include those that are only active against Pseudomonas aeruginosa or Acinetobacter baumannii.

 

       
Location: Tommy Douglas Conference Center Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic and Analgesic Drug Products AdComm and DSRM AdComm

Meeting Date: 4/5/17-4/5/17

Meeting Details:

The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 9:15AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Nonprescription AdComm & DSRM AdComm

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

Meeting Details:

The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 4/4/17-4/5/17

Meeting Details:

On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. On April 5, 2017, in open session, the committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). During the closed session, the Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-3:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 3/29/17-3/29/17

Meeting Details:

During the morning session of March 29, 2017, the committee will discuss biologics license application (BLA) 761064, rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. The proposed indications (uses) for this product are for: (1) The treatment of patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab/hyaluronidase for subcutaneous injection in combination with chemotherapy, as single-agent maintenance therapy; (3) nonprogressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4) the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline based chemotherapy regimens; and (5) in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL). During the afternoon session, the committee will discuss new drug application (NDA) 209099, for binimetinib, submitted by Array BioPharma Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable or metastatic melanoma, with NRAS Q61 mutation as detected by an FDA-approved test, who have received prior treatment with checkpoint inhibitor therapy.

 

       
Location: Sheraton Related News Links: Not Available
Time: 8:00AM-12:30PM    
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Past Meetings

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