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Parikh Debarred

04/06/2012

Federal Register Notice: FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act debarring Jyotin Parikh for five y...

Guidance on User Fees for FDA Device Classification Info

04/06/2012

Federal Register Notice: FDA is making available, Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(...

Guidance on Requesting FDA Info on Device Classification

04/06/2012

Federal Register Notice: FDA is making available, Guidance for Industry and Food and Drug Administration Staff; FDA and Industry P...

Review Period Set for Teflaro

04/06/2012

Federal Register Notice: FDA has determined the regulatory review period for Takeda Pharmaceutical’s Teflaro is 2,118 days f...

Review Period Set for Latuda

04/06/2012

Federal Register Notice: FDA has determined the regulatory review period is 3,602 days for Dainippon Sumitomo Pharma Co.’s L...

Review Period Set for Natroba

04/06/2012

Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Natroba (spinosad) is 2,261 days fo...

Review Period Set for Datscan

04/06/2012

Federal Register Notice: FDA has determined the regulatory review period for GE Healthcare Ltd.’s Datscan (Ioflupane I-123 i...

Viibryd Review Period Set

04/06/2012

Federal Register Notice: FDA has determined the regulatory review period for Merck’s Viibryd (vilazodone hydrochloride) is 4...

ICH Guidance on Veterinary Stability Data

04/04/2012

Federal Register Notice: FDA is making available, Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL...

Panel to Discuss S&E of Atrial Septal Defect Occluders

03/28/2012

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24 fro...