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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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: 9/14/16-9/14/16

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Meeting Details:

The committee will discuss new drug application 208714, apaziquone for intravesical instillation, application submitted by Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this product is for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.

 

       
Location: Conference Center Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting: Psychopharmacologic & DSRM Drugs AdComm

Meeting Date: 9/14/16-9/14/16

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Meeting Details:

The committees will discuss a completed postmarketing-requirement randomized, placebo controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies to determine whether the findings support changes to product labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 9/20/16-9/21/16

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Meeting Details:

On September 20 and 21, 2016, the Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, "Dressing, Wound, Drug," and are considered "pre-amendments" because they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. As a part of the classification process, FDA is seeking committee input on the indications for use, risks to health, and safety and effectiveness of these wound care products, and how they should be classified. They may be classified in class I (general controls), class II (special and general controls), or class III (premarket approval (PMA), requiring demonstration of safety and effectiveness for each product). FDA believes some of these products may meet the definition of class II whereas others may meet the definition of class III in light of their intended use, composition, the extent of evidence of clinical benefit, and the risks they pose. For the subset of the these products that contain antibiotics, FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic & DSRM Drug Adcomm

Meeting Date: 10/5/16-10/5/16

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Meeting Details:

The committees will be asked to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting of the Bone, Reproductive and Urologic Drugs Advisory Committee

Meeting Date: 10/19/16-9/19/16

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Meeting Details:

The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia.

 

       
Location: tbd Related News Links: Not Available
Time: 8:15AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 8/16/16-8/16/16

Meeting Details:

On August 16, 2016, the committee will discuss and make recommendations regarding the appropriateness of clearing or approving of over-the-counter (OTC) diagnostic tests for the detection of pathogens causing infectious diseases, focusing on respiratory and sexually transmitted infections (STI). Currently, there are no OTC diagnostic tests for infectious diseases cleared or approved by CDRH. The committee will evaluate the risks and benefits to individual patients and to public health associated with clearing or approving OTC diagnostic tests for infectious diseases. Serious risks such as false negative results, false positive results, patient loss to medical followup, and the impact on surveillance of reportable infections will be addressed. Potential benefits such as reduction of infection transmission and increased access to testing will be discussed as well. The committee will also make recommendations on clinical study design, analytical study design, and acceptable performance criteria applicable to respiratory and STI diagnostic devices.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry & Clinical Toxicology Devices Panel of the Medical Devices AdComm

Meeting Date: 8/10/16-8/10/16

Meeting Details:

On August 10, 2016, the committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc. The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 8/4/16-8/4/16

Meeting Details:

The committees will discuss new drug application (NDA) 208630, morphine sulfate extended-release tablets, submitted by Egalet U.S., Inc., with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties. The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: tbd Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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