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FDA Commissioner Stephen Hahn told Congress yesterday that India is restricting exports of 13 active pharmaceutical ingredients (API) and the drug formulations made from them to protect its internal supply chain. Read More
The FDA issued a warning letter to KVK-Tech for serious violations at its Newtown, Pennsylvania drug manufacturing facility, including lax data integrity and investigations. Read More
Four of eight complex trial designs submitted in the FDA’s complex innovative trial design (CID) pilot program have been accepted for review, the agency said Monday. Read More
Sandoz has agreed to pay $195 million to settle charges related to the Department of Justice’s three-year antitrust investigation into the generic drug industry, the company announced yesterday. Read More
Opioid makers and 37 Attorneys General told an Ohio federal court that proposed attorney fees could derail a global settlement in the opioid multidistrict litigation. Read More