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Mallinckrodt is facing another class-action suit over the price of its H.P. Acthar Gel (repository corticotropin), this time from the city of Marietta, Georgia. Read More
CDER has launched a Controlled Substances Program (CSP) to help develop new policies and programs to encourage “appropriate access” to scheduled drugs. Read More
Former FDA Commissioner Scott Gottlieb warned a Senate committee yesterday of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. Read More
The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level serial numbers. Read More
Drug distributor Acetris Health prevailed yesterday in an appeals court ruling that the company can call its products U.S.-made even though the active pharmaceutical ingredients are sourced elsewhere. Read More
In comments to the FDA, drugmakers called on the agency to clarify in its draft guidance for biosimilar and interchangeable insulin products that the agency will still hold applicants to the current licensing standards. Read More