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Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what drug companies must do to ensure that their agreements with CMOS are clear and enforceable. Read More
The FDA has updated final guidance on safety testing for drug metabolites to conform to the ICH’s latest standards on toxicity detection and testing. Read More
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Read More
Outsourcing facilities and states have faulted the FDA for sluggish progress toward finalizing guidance documents on drug compounding and the differences between state and agency inspection protocols, according to the U.S. Government Accountability Office. Read More
The European Medicines Agency published new guidance on whether less comprehensive data can be used to support a new indication for a previously approved orphan drug product. Read More
The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. Read More