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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
After years of trying to pass legislation that would allow the U.S. government to negotiate with drugmakers on prescription drug prices for the Medicare program, the Democrat-controlled U.S. House of Representatives passed such a bill on Friday in a 220-207 vote. Read More