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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
A former Valeant executive has been charged and arrested for allegedly defrauding the company of millions by discouraging business with other pharmacies besides Philidor, and convincing it to agree to an option to purchase the specialty pharmacy. Read More
Oxygen and nitrogen were added to the list of medical gases subject to conditional label exemptions, while cyclopropane and ethylene were removed, according to a final rule from the FDA. Read More
The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance. Read More