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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
Indian pharma giant Dr. Reddy’s is still in hot water with the FDA over its API manufacturing plant in Srikakulam, Andhra Pradesh, which netted the firm yet another Form 483 for serious violations. 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In comments to the FDA, drugmakers called on the agency to clarify in its draft guidance for biosimilar and interchangeable insulin products that the agency will still hold applicants to the current licensing standards.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
The FDA hit an over-the-counter drug manufacturer in South China with a Form 483 for multiple violations, including missing operating procedures. Read More