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The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. 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
Clinical trial design in non-muscle invasive bladder cancer should depend on whether patients have active disease at the time of enrollment, the FDA said, in a draft guidance that focuses on developing drugs and biologics for disease that has not responded to standard bacillus Calmette-Guerin immunotherapy. Read More
A federal judge ruled that a generic version of Merck’s Nasonex developed by Teva Pharmaceuticals does not infringe patent claims covering the allergy treatment’s active ingredient. 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