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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 OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/30/19-5/31/19

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Meeting Details:

On May 30, 2019, the committee will discuss and make recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls). On May 31, 2019, the committee will discuss and make recommendations regarding the reclassification of certain absorbable hemostatic agents from Class III to Class II (special controls).

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 6/6/19-6/6/19

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Meeting Details:

The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment- intolerant or non-responsive multidrug-resistant tuberculosis (TB).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint DSRM and Anesthetic and Analgesic AdComm

Meeting Date: 6/11/19-6/12/19

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Meeting Details:

FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients. FDA frequently hears from patients and healthcare providers that higher dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. There is a strong association between higher opioid dose and duration/persistence of opioid analgesic therapy and assessing temporal relationships and independent effects of opioid dose and duration on the risks of both addiction and overdose is challenging. In addition, FDA acknowledges the complex and evolving landscape of the opioid epidemic, with myriad Federal, State, local, and payer efforts to encourage more judicious prescribing of opioid analgesics, and the growing threat of highly lethal illicit opioids. To better understand both the clinical utility and harms of higher dose opioid analgesics in the current environment, and to discuss the advantages and disadvantages of various potential risk management strategies, FDA brings these issues to an advisory committee to seek input and advice from the clinical, patient, public health, and research communities. In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/19/19-6/20/19

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Meeting Details:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of ODAC

Meeting Date: 6/20/19-6/20/19

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Meeting Details:

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website: https://www.fda.gov/?AboutFDA/?CentersOffices/?OfficeofMedicalProductsandTobacco/?OCE/?ucm544641.htm. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors. During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

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

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 orbidity 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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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

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

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 OptionsPharmaceutical Science and Clinical Pharmacology AdComm

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

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 OptionsAntimicrobial Drugs AdComm

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

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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Past Meetings

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