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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
While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action, five others refused to delist. Read More
The rationing scheme allegedly led to the death of one patient in 2010, and injured the health of four others, who were co-plaintiffs in the case. Read More
Chinese pharmaceutical company Sichuan Deebio Pharmaceutical has suspended manufacture of at least one active pharmaceutical ingredient bound for the U.S. marketplace and may be banned from importation altogether if it doesn’t correct multiple deficiencies cited in a scathing 483 inspection report, according to a warning letter issued earlier this month. Read More