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The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said Thursday. Read More
The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said Thursday at the DIA annual meeting. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling that Celgene did not infringe on a Teva subsidiary’s patent when it marketed its cancer drug Abraxane. Read More
Concerned about high treatment costs, the UK’s healthcare cost watchdog wants Gilead Sciences to provide more information on its blockbuster leukemia drug Zydelig before it will consider recommending its use. Read More
The FDA wants generics makers to design tablets and capsules to be similar in size and shape to their reference listed drug to ensure patient acceptance and compliance, according to final guidance issued Thursday. Read More
Merck & Co. has agreed to pay $5.9 million to settle a federal lawsuit claiming a former subsidiary promoted its pink eye drug for off-label uses. Read More
Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. Read More