We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA cited a combination drug-device product manufacturer in China for serious testing failures and other violations uncovered in an inspection of its facility northwest of Shanghai. Read More
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
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