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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

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

Meeting Details:

The committee will discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

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

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 OptionsMedical Imaging Drugs AdComm

Meeting Date: 2/14/13-2/14/13

Meeting Details:

On February 14, 2013, the committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 7/10/00-7/10/00

Meeting Details:

The committee will discuss biologic license application (BLA) 99-1407, Leutech(Technicium labeled TC99M anti/CD15 antibody injection), Palatin Technologies, Inc., imaging agent as an aid in the diagnosis of equivocal appendicitis.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 6/28/99-6/29/99

Meeting Details:

Section 121 of the Food and Drug Administration Modernization Act of 1997 directs the Food and Drug Administration to establish appropriate procedures for the approval of positron emission tomography (PET) drugs under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355. At this meeting, FDA will present its findings on the safety and effectiveness of three PET drugs -- Fludeoxyglucose F 18 Injection, Ammonia N 13 Injection, and Water O 15 Injection for particular indications based on review of published literature. The committee will discuss the safety and effectiveness data on these three drugs. FDA also will discuss its proposed procedures for obtaining marketing approval for these three PET drugs. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Holiday Inn Two Montgomery Village Avenue Gaithe Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 2/9/98-2/9/98

Meeting Details:

The commitee will discuss the safety and efficacy of new drug application (NDA) 20-887 AcuTectTM (Technetium Tc99m apcitide) for the detection and localization of acute venous thrombosis. The sponser is Diatide, Inc.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 7/22/96-7/23/96

Meeting Details:

The committee will discuss the Center for Biologics Evaluation and Research's product license application 95- 0041 for Prostascint TM (Cytogen Corp.), a radiolabeled monoclonal antibody designed to detect sites of metastatic cancer which express the prostate specific membrane antigen.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs

Meeting Date: 2/15/96-2/16/96

Meeting Details:

The committee will discuss and begin drafting ``Points to Consider (PTC) for Developing Medical Imaging Agents.'' The purpose of the meeting is to provide the committee opportunity to work together on this draft and not primarily to hear presentations. The agents encompassed will include radiologic contrast media and nuclear medicine pharmaceuticals. The committee will discuss product license application (PLA) 91-0209, from Immunomedics, for Immu-4, a murine monoclonal antibody fragment directed against the carcinoembryonic antigen (CEA).

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 10/26/95-10/26/95

Meeting Details:

The committee will hold a preliminary discussion in preparation for drafting of future ``Points to Consider for Diagnostic Imaging Agents''.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel - Sponsor: Sequent Medical, Inc.

Meeting Date: 9/27/18-9/27/18

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Meeting Details:

On September 27, 2018, the Committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Sequent Medical, Inc. for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in the WEB Intrasaccular Therapy Study (WEB-IT): a multicenter, prospective, non-randomized investigation. The Committee will be asked to review the clinical data from the WEB-IT study to help the Agency assess the safety and effectiveness of the device for the proposed indications for use.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm - Sponsor: Genentech & Celltrion

Meeting Date: 10/10/18-10/10/18

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Meeting Details:

The committee will discuss biologics license application 761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN (rituximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B- cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to CT-P10 in combination with chemotherapy, as single- agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: Trevena Inc.

Meeting Date: 10/11/18-10/11/18

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will also be asked to discuss the efficacy and safety data and benefit-risk considerations.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: AcelRX

Meeting Date: 10/12/18-10/12/18

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee will also be asked to discuss risk- benefit considerations and whether this product should be approved.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal & DSRM AdComm - Sponsor: Sloan Pharma

Meeting Date: 10/17/18-10/17/18

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Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.[agrave].r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Sponsor: Shire

Meeting Date: 10/18/18-10/18/18

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Meeting Details:

The committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/24/18-10/25/18

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Meeting Details:

Agenda: On both days, the committee will discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and biologics for the treatment of type 2 diabetes mellitus.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

The meeting will focus on two topics related to the Office of Pharmaceutical Quality’s priority of promoting the availability of better medicine. During the morning session, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment. During the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

 

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

Meeting Date: 9/20/18-9/20/18

Meeting Details:

On Thursday, September 20, 2018, the PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155). The PAC will meet to discuss the following Center for Drug Evaluation and Research products: INTUNIV LEXAPRO The FDA will provide general safety updates including updates on the following topics without vote by the committee: Overview of FAERS and lack of efficacy; Generic drug approval process; and discussion on trade versus generic drugs; exceptions; Summary of FDA completed review of pediatric safety issues and updated labeling changes for Exjade (deferasirox); Update labeling change for inhaled corticosteroid long-acting ß-2 agonists (ICS/LABAs); Safety labeling for gadolinium.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 9/12/18-9/12/18

Meeting Details:

The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the 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. Drug - > Uses Reviewed - >(alpha lipoic acid) Diabetic neuropathy and associated pain, acute liver toxicity from Amanitaspp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain (coenzyme Q10) Mitochondrial disorders (creatine monohydrate) Mitochondrial disorders (pyridoxal 5 phosphate) Epilepsy and seizure disorders (choline chloride) Hepatic steatosis, supplementation in long term total parenteral nutrition, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis (quercetin dihydrate) Asthma, allergy, cancer prevention and treatment, and hypertension

 

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

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