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The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Read More
A new class-action lawsuit from a terminal blood cancer patient claims that Celgene abused consumer safety regulations to monopolize cancer drugs. Read More
The White House could be pushing for lower prices by way of speeding drugs to market and promoting competition—even internationally—according to a draft executive order that could have the president’s signature soon. Read More
To help drive down drug prices, the FDA plans to list drugs and drug categories where patent and exclusivity protection have expired, but no generic entrants are available, FDA Commissioner Scott Gottlieb said Monday, in his first address to the agency’s Science Board. Read More
The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Read More
CDER’s Office of New Drugs established policies and procedures for review staff for the management of financial disclosure information submitted in NDAs, BLAs and supplemental applications. Read More
The maker of an over-the-counter sleep aid has been warned by the FDA for marketing and branding a product with a name that may cause consumers to confuse it with an older prescription drug no longer on the market. Read More