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Several leading drugmakers — including Janssen, Novo Nordisk and Genentech — urged the FDA to include new information on interchangeable products in the agency’s Purple Book, which lists biological products including biosimilars and interchangeables licensed by the agency. Read More
In new draft guidance issued Friday, the FDA outlined what it expects sponsors to include in submissions of use-related risk analyses, threshold analyses, comparative use human factors (HF) and HF validation study protocols and reports. Read More
The FDA Friday issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and get treatments to market more swiftly and efficiently. Read More
The compromise measure includes a provision from the Senate bill requiring prescription opioids to be packaged in three- or seven-day blister packs. Read More
The agency will not take action against facilities that compound a radiopharmaceutical that is essentially a copy of an approved drug with “minor deviations.” Read More
One bill would ban the practice specifically for individual-market plans and employer sponsored group plans, while the other would prohibit it for Medicare Part D or Medicare Advantage plans. Read More
The FDA’s final guidance on non-proprietary naming for biologics directs both reference products and biosimilars to share the same core name, with both products bearing a different four-letter suffix. Read More
The complaint alleges AstraZeneca deployed nurses to illegally recommend three drugs to doctors and patients under the guise of offering expert advice. Read More
Mylan and Novartis criticized the FDA’s use of arbitrary suffixes in a non-proprietary naming convention for biologics in comments about a Sept. 4 a public hearing aimed at promoting biosimilars and interchangeable products. Read More
The company responded to the Form 483 observations on Aug. 24 and provided more information in the following weeks to address the agency’s concerns. Read More