APR 12 ODAC

February 14, 2016 jessica adams

Clovis Oncology, Inc.'s rociletinib tablets for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test

MAR 8-9 PCAC

February 10, 2016 jessica adams

Nominations for the bulk drug substances allowed list: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine

Nominations for the demonstrably difficult list: metered dose inhalers and dry powder inhalers

MAR 29 PDAC

January 29, 2016 jessica adams

Acadia's Nuplazid (pimavanserin) for Parkinson's disease

JAN 22 PCNS

December 17, 2015 jessica adams

Sarepta Therapeutics' eteplirsen for Duchenne muscular dystrophy

FEB 3 PDAC

November 28, 2015 jessica adams

Morning session - Is cognitive dysfunction in MDD a distinct entity?

Afternoon session- Takeda's vortioxetine for the treatment of cognitive dysfunction in MDD

JAN 14 VRBPAC

November 25, 2015 jessica adams

Research updates from CBER's Laboratory of Method Development, Viral Products

DEC 14 EMDAC

November 10, 2015 jessica adams

Results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)

NOV 18 ODAC-CTGTAC

September 28, 2015 jessica adams

Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), by Telesta Therapeutics Inc. for the treatment of non-muscle invasive bladder cancer

DEC 9 PADAC

September 18, 2015 jessica adams

Teva’s reslizumab for asthma

DEC 1 PDAC

September 8, 2015 jessica adams

Gepirone ER by Fabre-Kramer Pharmaceuticals, inc. for major depressive disorder

SEP 16 PEDAC

August 11, 2015 jessica adams

Pediatric review of 18 products required by PREA/BPCA/PMDSIA

SEP 11 AADPAC-DSRM

August 7, 2015 jessica adams

Collegium's oxycodone extended-release tablets: food effects and abuse deterrence

SEP 10 AADPAC-DSRM

August 7, 2015 jessica adams

Purdue’s oxycodone immediate-release tablets: food effects and abuse deterrence

JUL 29 SBFDA

July 10, 2015 jessica adams

Topics include: the Commissioner’s Fellowship Program Evaluation subcommittee, the Science Looking Forward subcommittee, scientific activities from the Center for Veterinary Medicine, strategies contained in the National Strategy for Combating Antibiotic - Resistant Bacteria, scientific Achievement Awards, the 21st Century Cures Act, and the vision for the Office of Medical Products and Tobacco.

JUL 7 AADPAC-DSRM

May 28, 2015 jessica adams

Purdue's OXYCONTIN ER: Do studies show the reformulation has meaningful impact on abuse?

JUL 9 ODAC

May 21, 2015 jessica adams

Eli Lilly and Co.'s necitumumab injection, in combination with gemcitabine and cisplatin, for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer

JUN 17-18 PCAC

May 21, 2015 jessica adams

Revisions to the drugs that may not be compounded and allowed bulk drug substances. Discussion about the identification of a substance as demonstrably difficult to compound