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To shift thinking on quality, Phillips said, quality departments must communicate with the rest of the organization in a way that makes clear why an action or correction is essential, rather than starting with the “what” or the “how.” Read More
Clinical trials of drugs for treatment of chronic hepatitis B viral infections may use multiple efficacy endpoints, the FDA said in new draft guidance released Thursday. Read More
An FDA advisory panel Thursday voted against the effectiveness and benefit-risk profile of Alkermes’ NDA for buprenorphine/samidorphan to treat major depressive disorder but in favor of its safety. Read More
“A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure,” the ruling states. Read More
A federal appeals court has backed up the FDA’s decision to block prescription generics of Bayer’s MiraLax after the branded version switched to over-the-counter status. Read More
HHS invoked its emergency authority to bypass Office of Management and Budget review to quickly roll out a survey to assess prescribing trends for buprenorphine. Read More