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None of the nine pharmacy benefit managers (PBM) ordered in 2022 and 2023 to turn over business practice documents to the FTC have fully complied, FTC Chair Lina M. Khan told a bipartisan group of legislators who wrote in January seeking an update on the inquiry. Read More
The problem of potentially illicit, contaminated or low-potency counterfeit drugs coming into the U.S. from other countries is “huge,” but the government doesn’t have a handle on the true numbers, said FDA Commissioner Robert Califf on Wednesday during a Reuters Newsmakers webinar. Read More
This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for molecular glue. Read More
A finalized FDA guidance outlines how drug manufacturers and all registrants of drug establishments should report the “amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.” Read More
Topical ophthalmic drug developers have asked the FDA for greater clarity on evaluating visible particulate matter, extractables and leachables, and petitioned the agency for more specifics on quality issues, as the comment period closed Monday on a revised guidance for such products. Read More
A robust package of success stories highlights the FDA’s Office of Generic Drugs (OGD) 2023 Annual Report, with ample credit given to Congress’ reauthorization of a program ensuring safe and effective generic medicines. Read More
Wholesale drug acquisition and distribution stakeholders say that even by November, the industry won’t be ready to comply with the Drug Supply Chain Security Act’s (DSCSA) updated security requirements. Read More
The FDA has issued a new final guidance on assessing COVID-19-related symptoms in drug and biologics trials for outpatient prevention/treatment of the infectious disease, overriding its prior recommendations from September 2020. Read More