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After facing years of delays, HHS has put its foot down on a final rule establishing fines for drugmakers that knowingly overcharge “safety-net” healthcare providers. Read More
The FDA logged a steadily increasing number of fast-tracked ANDAs in fiscal year 2018, according to the agency’s first annual report mandated by the FDA Reauthorization Act. Read More
A joint FDA advisory committee Friday voted in favor of the effectiveness, safety and risk-benefit profile of Sage Therapeutics’ NDA for the treatment of post-partum depression. Read More
The petition comes on the heels of a decision by the Eighth Circuit Court of Appeals, which declared that Act 900 was partially preempted by the Medicaid Part D and Employee Retirement Income Security Act of 1974 (ERISA). Read More
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of drugs for treatment of chronic hepatitis B viral infections may use multiple efficacy endpoints, the FDA said in new draft guidance released Thursday.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