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The FDA has issued a warning letter to About Mineral, an Orange, Ca-based company that sells Puriton, a direct-to-consumer line of topical skin products which it claims have been tested and are effective against COVID-19. Read More
The U.S. Special Counsel has released details of a former FDA inspector’s allegations against the agency, including that it may have dropped the ball in an inspection of a Merck plant and possibly downgraded certain inspection findings without filing required documentation, claims he described as “troubling” in a letter to the White House. Read More
In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance. Read More
FDA investigators observed multiple problems at Emergent BioSolutions’ beleaguered Bayview facility in an April 12 to April 20 inspection prompted by a manufacturing mix-up for Johnson & Johnson (J&J)’s and AstraZeneca (AZ)’s COVID-19 vaccines, making it unlikely that the plant will be authorized to produce J&J doses anytime soon. Read More
The FDA is preparing to conduct what it’s calling the first-ever systemic study examining how pharmaceutical brand names influence perceptions about drug efficacy. Read More
The FDA sent a warning letter to Dibar Nutricional, an over-the-counter drug manufacturer in Morelia, Mexico, after a records-based inspection revealed significant lapses at the facility. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, an over-the-counter (OTC) drugmaker in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch. Read More
The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs). Read More
Drug manufacturers need to document and report to the FDA if they haven’t been able to comply with postmarket adverse drug experience (PADE) reporting requirements during the COVID-19 pandemic, a former agency compliance official advised. Read More
The Government Accountability Office (GAO) released a new report warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools. Read More