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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
Bavarian Nordic is chiding the FDA after the agency recommended intradermal (ID) administration of Jynneos, the company’s monkeypox vaccine, in its Aug. 11 Emergency Use Authorization (EUA). Read More
A new FDA study of character-space-limited (CSL) communications to promote prescription drugs showed that patients understood a drug’s risk better when the risk was included in an initial tweet rather than in a link to that information located on a separate landing page. Read More
New evidence shows that an additional 135 million COVID-19 vaccine doses manufactured at the troubled Emergent BioSolutions’ Bayview, Md., facility will need to be destroyed following the discovery of quality deficiencies. Read More