[ Price : $8.95]
Federal Register Notice: FDA withdraws a draft guidance, Class II Special Controls Guidance Document: External Pacemaker Pulse Gen...[ Price : $8.95]
CDERs Office of New Drugs denies an Amarin appeal of its rescission of a clinical trial special protocol assessment agreement unde...[ Price : $8.95]
CDER partially grants and denies NDA-related concerns raised in a citizen petition asking FDA to rescind its 510(k) clearance of a...[ Price : $8.95]
A new report from McKinssey & Co. questions the benefits to drug makers of being the to market.[ Price : $8.95]
Hospira recalls one lot of Heparin Sodium, 1,000 USP heparin units/500 ml in 0.9% sodium chloride injection due to a report of par...[ Price : $8.95]
The Washington DC federal district court grants a Depomed motion for summary judgment compelling FDA to award Gralise (gabapentin)...[ Price : $8.95]
A Frankfurt Kurnit Klein & Selz advertising law alert describes the safe harbor FDA created in its recent draft guidance on Intern...[ Price : $8.95]
FDA gains OMB approval to conduct research into eye movements of volunteers watching a direct-to-consumer TV ad to determine wheth...