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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
The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave its blessing for European Commission approval of two drugs at its February meeting, including a generic version of Pfizer’s skin infection medication Tygacil (tigecycline). Read More
The FDA unveiled a pilot program last week that will use plain language and podcasts to explain its guidance documents in snapshots posted to its website. Read More
The FDA reported the first U.S. drug shortage linked to the novel coronavirus outbreak — but did not name the drug. It is likely pindolol, a beta blocker for treatment of blood pressure manufactured by Mylan and Sun Pharma. Read More