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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bladder cancer should depend on whether patients have active disease at the time of enrollment, the FDA said, in a draft guidance that focuses on developing drugs and biologics for disease that has not responded to standard bacillus Calmette-Guerin immunotherapy.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
House Republicans have asked all federal agencies to postpone rulemaking until President-elect Donald Trump’s administration and the newly elected Congress assume office next year. Read More
Three clinical trial designs incorporating real-world evidence were proposed by a working group consisting of members the FDA and industry, who said the trials could possibly be used in future regulatory decisions. Read More
Sen. Charles Grassley (R-Iowa) is calling on the Justice Department to reconsider testifying before the House Judiciary Committee on its settlement with Mylan, which resolved allegations that the company overcharged Medicaid for its allergy therapy, the EpiPen. Read More