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FDA Releases Guidance on CMC Postapproval Changes

March 4, 2014

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Report: Branded Biopharms Most Exposed to Biosimilar Competition

February 26, 2014

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

FDA Issues Draft Guidance on NCE Exclusivity Determinations

February 25, 2014

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

FDA Updates Analytical Validation Guidance

February 19, 2014

FDA provides recommendations for submitting analytical procedures and methods validation data.

FDA and EMA Collaborate on Pharmacovigilance

February 19, 2014

FDA and EMA set up regular meetings to harmonize drug safety actions.

FDA Initiates Secure Supply Chain Pilot Program

February 18, 2014

Thirteen companies are accepted for participation in the supply chain program.

Ben Venue Laboratories Issues Voluntary Recall Of Acetylcysteine Solution

February 18, 2014

Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.

Nearly 200 New Medicines in Development for Diabetes

February 13, 2014

New medicines in development include treatments for type 1 and type 2 diabetes.

New European Program Targets Novel Antibiotics

February 13, 2014

Innovative Medicines Initiative will develop novel antibiotics against gram-negative pathogens in a project called ENABLE.

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