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The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More
The tax puts generic drug manufacturers in the crosshairs, according to the group, because generics account for 90 percent of the volume of prescriptions dispensed but only 23 percent of spending. Read More
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