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Egalet U.S. morphine sulfate extended-release tablets Advisory Committee Meeting

08/04/2016 - 08:00
08/04/2016 - 16:00

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UPDATED Webnotice: August 4, 2016: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

UPDATED INFORMATION
The Agenda portion has been changed for the August 4, 2016 Joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. There are no other changes.

The Agenda portion is changed to correct the new drug application number and read as follows:

Valeant Pharmaceuticals brodalumab injection FDA Advisory Committee Meeting

07/19/2016 - 08:00
07/19/2016 - 17:00

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July 19, 2016: Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement

Center Date Time Location
CDER July 19, 2016
8:00 a.m. to 5:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Agenda

Amgen ABP 501 FDA Advisory Committee Meeting

07/12/2016 - 07:30
07/12/2016 - 17:00

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Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab

THOUSAND OAKS, Calif., June 13, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).

Sarepta Therapeutics Eteplirsen FDA Advisory Committee Meeting

04/25/2016 - 08:00
04/25/2016 - 16:30

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Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
--Advisory Committee Meeting Rescheduled for April 25, 2016--
--PDUFA date for eteplirsen is May 26, 2016--

Clovis Oncology Rociletinib FDA Advisory Committee Meeting

04/12/2016 - 07:00
04/12/2016 - 16:00

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CLOVIS ONCOLOGY ANNOUNCES ROCILETINIB NEW DRUG APPLICATION SCHEDULED FOR PRESENTATION AT UPCOMING FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING

ACADIA Pharmaceuticals Nuplazid FDA Advisory Committee Meeting

03/29/2016 - 08:00
03/29/2016 - 16:00

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ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis
Advisory Committee Meeting Scheduled for March 29, 2016

Intercept Pharmaceuticals Obeticholic Acid FDA Advisory Committee Meeting

04/07/2016 - 08:30
04/07/2016 - 17:00

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FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC

Teva reslizumab FDA Advisory Committee Meeting

12/09/2015 - 08:00
12/09/2015 - 17:00

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December 9, 2015: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
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Center Date Time Location
CDER December 9, 2015
8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland

Agenda

Merck ezetimibe/simvastatin Advisory Committee Meeting

12/14/2015 - 08:00
12/14/2015 - 17:00

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December 14, 2015: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
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Center Date Time Location
CDER December 14, 2015 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland
Agenda

BioMarin Pharmaceutical Drisapersen FDA Advisory Committee

11/24/2015 - 08:30
11/24/2015 - 16:30

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BioMarin Announces FDA Advisory Committee to Review Drisapersen for Treatment of Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

Advisory Committee Meeting Scheduled for November 24, 2015

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