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Colorado has chosen three supply chain partners to help the state import lower-cost medications from Canada, in anticipation of getting the FDA’s approval to launch the program. Read More
The number of drug units impacted by recalls in the second quarter of 2022 was slashed by more than half — from 435.3 million units recalled in Q1 to 20.6 million — in Q2, the lowest number of units in the past five quarters, according to Sedgwick, a company that specializes in product recalls and remediation. Read More
A federal court judge in Delaware has ruled in favor of Exela Pharma Sciences on all counts in a patent dispute over Eton Pharmaceuticals’s abbreviated new drug application (ANDA) to produce a generic version of Exela’s product Elcys. Read More
The FDA issued a warning letter to Verde Cosmetics of Northridge, Calif., for failing to conduct microbiological testing of its topical drugs and lacking adequate cleaning procedures. Read More
Piling more criticism on the already-embattled Emergent Biosolutions, the FDA has issued a warning letter citing significant sterility issues at the company’s Camden facility in Baltimore, Md., and stating that Emergent’s management oversight and control over the manufacture of drugs is inadequate. Read More
Drug and biologics manufacturers submitting electronic individual case safety reports (ICSR) and ICSR attachments to the FDA Adverse Event Reporting System database should follow a new technical guide the agency released yesterday. Read More