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The FDA still plans on finalizing the highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
A federal judge upheld the FDA’s decision to strip Ranbaxy of its tentative ANDA approvals for two drugs because of GMP problems at manufacturing facilities, but nonetheless blasted the agency, saying it never should have issued the approvals in the first place. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week. Read More
The FDA needs to work with devicemakers and Congress to understand why clinical development takes longer here than in other countries and then implement changes to speed up the process, a new study concludes. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them to a researcher, setting up a test case for the EU’s new trial transparency policy. Read More