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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 4/7/16-4/7/16

Meeting Details:

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

 

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

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Meeting OptionsMeeting OptionsMeeting Options*** Meeting Delay *** Joint GIDAC & DSaRM

Meeting Date: 12/9/13-12/9/13

Meeting Details:

On December 9, 2013, the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Millennium Pharmaceuticals, Inc. BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa) antagonist. BLA 125507 proposes an indication for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNFa antagonist.

 

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

Meeting Date: 10/16/12-10/16/12

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 203441, with the proposed trade name GATTEX (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Gastrointestinal Drugs AdComm

Meeting Date: 10/15/12-10/15/12

Meeting Details:

The committee will provide advice and recommendations to the Agency on the need for and design of clinical development programs necessary to support approval of parenteral lipid emulsion products as nutritional support. FDA intends to make background material available to

 

       
Location: White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 8/28/12-8/28/12

Meeting Details:

The committee will discuss the results from clinical trials of supplemental biologics license application (sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for the proposed indication (use) for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

 

       
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 3/13/12-3/13/12

Meeting Details:

The committee will discuss and provide general advice on the appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia (increased levels of bilirubin in the body) in newborn infants.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 11/16/11-11/17/11

Meeting Details:

On November 16th, the committee will discuss the design of clinical trials to evaluate the safety, efficacy and durability of response with repeat treatment cycles of XIFAXAN (rifaximin) by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. On November 17th, the committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5-hydroxytryptamine) receptor 4 (5HT4) agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation (CIC), constipation predominant irritable bowel syndrome (IBS-C), gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.

 

       
Location: Hilton Inn Washington/College Park Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsREMICADE by Centocor - Gastrointestinal Drugs AdComm

Meeting Date: 7/21/11-7/21/11

Meeting Details:

On July 21, 2011, the committee will discuss the results from a clinical trial of supplement biologics license application 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 1/12/11-1/12/11

Meeting Details:

On January 12, 2011, the committee will discuss the safety and efficacy of new drug application (NDA) 022-486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas. The pancreas is an organ involved, in part, in the digestion of food through the use of specialized proteins called enzymes. Exocrine pancreatic insufficiency is a decreased ability to digest food due to deficient enzyme production by the pancreas.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 11/4/10-11/5/10

Meeting Details:

On November 4, 2010, the committee will discuss the adequacy of endoscopically documented gastric ulcers as an outcome measure to evaluate drugs intended to prevent gastrointestinal complications of nonsteroidal anti-inflammatory drugs including aspirin. The purpose of this meeting is to discuss results from clinical trials of proton pump inhibitors in astroespohageal reflux disease (GERD) in patients less than one year of age, performed in response to a Pediatric Written Request under the Best Pharmaceuticals for Children Act (Nexium, esomeprazole by AstraZeneca LP; Prevacid, lansoprazole by Takeda Pharmaceuticals North America, Inc; Protonix, pantoprazole by Pfizer, Inc.) and Pediatric Research Equity Act (PREA) commitment (Prilosec, omeprazole by AstraZeneca LP). The pathophysiology (disease process) of GERD, its diagnosis and management, and issues related to the design of clinical trials in this age group will be considered.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Salix Pharmacueticals

Meeting Date: 2/23/10-2/23/10

Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 22-554 for XIFAXAN (rifaximin) Tablets 550 mg, manufactured by Salix Pharmaceuticals, for the indication (use) of maintenance of remission of hepatic encephalopathy, a condition in which severe liver disease contributes to an accumulation of toxic substances that impair brain function. This indication is for patients 18 years of age and older.

 

       
Location: Hilton Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Day 2 Cancelled

Meeting Date: 5/19/09-5/20/09

Meeting Details:

On May 19th the committee will discuss the safety and efficacy of new drug application (NDA) 21761, SANVAR (vapreotide acetate) by Debiovision, Inc., for the proposed indication as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension.

 

       
Location: Hilton Washington Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 1/23/08-1/23/08

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 21-775, ENTEREG (alvimopan), Adolor Corp., for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal and DSRM AdComm

Meeting Date: 7/31/07-7/31/07

Meeting Details:

The committee will discuss TYSABRI (natalizumab) biologic license application (BLA) 125104/33, Biogen Idec, Inc., for the proposed indication of inducing and maintaining sustained response and remission, and eliminating corticosteroid use in patients with moderately to severely active Crohn's disease with inflammation, as evidenced by elevated C-reactive protein level or another objective marker. The committee will discuss the risks (including progressive multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) administration, its efficacy in the treatment of moderate to severe Crohn's disease, and proposed risk management plan(s).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 3/9/05-3/9/05

Meeting Details:

The FDA will meet to discuss Solvay Pharmaceutical Inc. Cilansetron. Related Link From Yahoo

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 7/14/04-7/14/04

Meeting Details:

The FDA will meet to consider Zelnorm by Novartis for the treatment of chronic constipation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 6/25/03-6/26/03

Meeting Details:

On June 25, the committee will discuss new drug application (NDA) 21-297, SEROSTIM (somatropin), Serono, Inc., for the treatment of short bowel syndrome in patients receiving specialized nutritional support. SEROSTIM therapy should be used in conjunction with optimal management of short bowel syndrome. On June 26, the committee will discuss NDA 21-525, PHOTOFRIN (porfirmer sodium), Axcan Scandipharm, Inc. Photodynamic therapy with PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus among patients who refuse esophagectomy and who are in overall good health.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 3/6/03-3/6/03

Meeting Details:

On March 6, 2003, the committee will discuss new drug application (NDA) 21-549, EMEND (aprepitant) Capsules, Merck & Co., Inc., for the following indication: "EMEND, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin."

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 4/23/02-4/23/02

Meeting Details:

GlaxoSmithKline Lotronex (alosetron) Discussion of risk management issues for withdrawn drug

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs Advisory Committee

Meeting Date: 3/19/02-3/19/02

Meeting Details:

The committee will discuss standards in study designs of clinical trials testing the efficacy and safety of chemopreventive agents that are being developed to gain FDA approval in reducing the risk of sporadic colorectal adenomatous polyps and sporadic colorectal cancer.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 6/26/00-6/27/00

Meeting Details:

On June 26, 2000, the committee will discuss new drug application (NDA) 21-200, Zelmac TM (tegaserod), Novartis Pharmaceuticals Corp., for the treatment of abdominal pain and discomfort, bloating and altered bowel function in patients with irritable bowel syndrome who have predominant symptoms of pain, discomfort, and constipation. On June 27, 2000, the committee will discuss risk management of post-marketing adverse events associated with NDA 21-107, LotronexTM (alosetron) Glaxo Wellcome.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 4/12/00-4/12/00

Meeting Details:

The committee will discuss current information on the safety of Janssen Pharmaceutica's Propulsid(cisapride) and methods to reduce the occurrence of adverse events associated with its use.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 11/16/99-11/16/99

Meeting Details:

The committee will discuss new drug application (NDA) 21-107, Lotronex™ (alosteron HCI), Glaxo-Wellcome Pharmaceuticals, to be indicated for treatment of irritable bowel in female patients with diarrhea predominance.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 5/28/98-5/29/98

Meeting Details:

On May 28, 1998, the Committee will discuss biologics license application, 98-0012, Centocor, Inc’s Avakine™ (Infliximax), for treatment of patients with Crohn’s disease. An indication is sought to: 1)reduce signs and symptoms in patients with moderate to severe disease activity in whom conventional therapies are inadequate and, 2) to close entercutaneous fistulas. On May 29, 1998, the Committee will hold a general discussion on guidance for study of drugs to treat Crohn’s disease.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 11/4/96-11/5/96

Meeting Details:

On November 4, 1996, the committee will discuss data concerning the safety of long-term antisecretory therapy in patients with Helicobacter pylori; new drug application (NDA) 19- 810, Prilosec (omeprazole, Astra Merck), delayed release capsules; and NDA 20-406, Prevacid (lansoprazole, TAP Holding Co.), delayed release capsules. On November 5, 1996, the committee will discuss NDA 20-675 (ureodeoxycholic acid, Axcan Pharma), for the treatment of patients with primary biliary cirrhosis.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 9/28/95-9/28/95

Meeting Details:

Nonprescription Drugs Advisory Committee and some members of the Gastrointestinal Drugs Advisory Committee will discuss data relevant to NDA 20-555 for nizatidine tablets, 75 mg, sponsored by Whitehall-Robins Healthcare to switch the product from prescription to over-the-counter status for the prevention of meal and beverage induced heartburn.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 7/13/95-7/13/95

Meeting Details:

On July 13, 1995, the Nonprescription Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee will discuss data relevant to NDA 20-520 to switch Zantac 75 (ranitidine hydrochloride tablets) (Glaxo, Inc.) from prescription to over-the-counter status for the treatment of heartburn.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 7/12/95-7/12/95

Meeting Details:

The committee will discuss new drug application (NDA) 20-458, Lemmon Co., zinc acetate to be indicated for use in Wilson's disease. The advisory committee will also consider draft ``Points to Consider'' from the Division of Anti-Infective Drug Products on Helicobacter pylori studies to prevent peptic ulcer recurrence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 3/27/95-3/28/95

Meeting Details:

On March 27, 1995, the Nonprescription Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee will discuss SmithKline Beecham's NDA 20-238 for over-the- counter (OTC) Tagamet (cimetidine) tablets for the treatment of heartburn. On the morning of March 28, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee will discuss data relevant to NDA 20-516 for ibuprofen suspension (Motrin, McNeil Consumer Products) for the treatment of fever and of pain in children between 2 and 12 years of age. On the afternoon of March 28, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee will discuss recommendations regarding appropriate OTC indication(s) for muscle relaxants, OTC dose(s) and duration of use, safety profiles, abuse potential, and pharmacokinetic information.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 12/1/94-12/2/94

Meeting Details:

On December 1, 1994, the committee will discuss new drug application (NDA) 20-406, TAP Pharmaceuticals, Prevacid (lansoprazole), to be indicated for the treatment of reflux esophagitis, maintenance of healing of reflux esophagitis, duodenal ulcer and hypersecretory conditions including Zollinger- Ellison syndrome. On December 2, 1994, the committee will discuss NDA 19-810, Astra-Merck, Prilosec (omeprazole) for maintenance treatment of gastroesophageal reflux disease.

 

       
Location: December 1, 1994, 9 a.m., and December 2, 1994, 8:30 a.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 7/29/94-7/29/94

Meeting Details:

The committees will discuss NDA 20-325, Pepcid (famotidine), Merck and Co., for treatment and prevention of episodic heartburn.

 

       
Location: July 29, 1994, 9 a.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 7/28/94-7/28/94

Meeting Details:

The committee will discuss NDA 19-594 (supplement 015), Ciba-Geigy Corp., Actigall (ursodiol) for treatment of primary biliary cirrhosis. Closed committee deliberations. The committee will discuss trade secret and/or confidential commercial information relevant to pending investigational NDA's. This portion of the meeting will be closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).

 

       
Location: July 28, 1994, 9 a.m., Parklawn Bldg., conference rms. G, H, I, and J, 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Gastrointestinal Drugs

Meeting Date: 7/27/94-7/28/94

Meeting Details:

The committees will jointly discuss new drug application (NDA) 20-238, Tagamet (cimetidine), SmithKline Beecham, for treatment of episodic heartburn as an over-the-counter product.

 

       
Location: July 27, 1994, 9 a.m., conference rms. D and E, Parklawn Bldg., FDA 5600 Fishers Lane, Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

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

Broadcasting Live NOW

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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 6/20/17-6/20/17

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Meeting Details:

The committee will discuss a supplemental new drug application for VICTOZA (liraglutide) injection (sNDA 022341), sponsored by Novo Nordisk, for the proposed additional indication of: As an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Pediatric AdComm and the Pediatric Ethics Subcommittee

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

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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices AdComm

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

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 OptionsVaccines and Related Biological Products AdComm

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

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    
Materials:
   
       

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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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

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

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    
Materials:
   
       

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Past Meetings

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

Live Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

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

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Meeting Description:

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    
Materials:
   
       

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