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The draft puts day zero at the day the contract laboratory learns there’s a problem; existing regulations put day zero at the day the NDA or ANDA applicant learns there’s a problem. Read More
The CBO score validates what AAM and our member companies have been saying for years: that CREATES will reduce drug prices and increase access to medicines for patients who need it most,” said Rachel Schwartz, a spokesperson for the Association for Accessible Medicines. Read More
A Delaware court on Monday sided with Fresenius in its bid to pull out of a planned $4.3 billion merger with Akorn because of alleged fraud and falsified testing data submitted to the FDA. Read More
A provision in the proposed U.S.-Mexico-Canada Agreement that would give branded biologics makers a decade of exclusivity goes against the White House’s stated priority of improving access to biosimilars, according to the Association for Accessible Medicines (AAM). Read More
Under the current labeling regulations, the senators noted, sponsors of older brand-name drugs with expired patents have little incentive to update labeling. Read More
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In new draft guidance issued Friday, the FDA outlined what it expects sponsors to include in submissions of use-related risk analyses, threshold analyses, comparative use human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