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FDA Issues Draft Guidance on NCE Exclusivity Determinations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 and EMA Collaborate on Pharmacovigilance

February 19, 2014

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

FDA Updates Analytical Validation Guidance

February 19, 2014

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

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.

Tandem Diabetes Care Expands Recall

February 13, 2014

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

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.

EMA Clarifies New Variation Classification Categories

February 11, 2014

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

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