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Reports of a vulnerability in the Blackberry operating system used in some pharmaceutical manufacturing equipment as well as in certain medical devices and device manufacturing has prompted the FDA to issue a cybersecurity alert. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) has issued its third untitled letter of the year to Deer Park, Ill.-based Eton Pharmaceuticals over advertisements for the company’s Alkindi Sprinkle (hydrocortisone) oral granule, a treatment for the pediatric hormone disorder adrenocortical insufficiency. Read More
Several drugmakers have offered suggestions in written comments to the FDA for revisions to the agency’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube. Read More
The FDA has finalized a guidance on one aspect of drug quality assessment: “Development and Submission of Near Infrared Analytical Procedures,” abbreviated NIR. Read More
The FDA observed a variety of quality issues during inspections of four drug facilities, including inadequate environmental monitoring, reviews of batch records, non-microbial contamination and — in one case — the lack of a quality unit. Read More
The FDA issued a warning letter to Syntec Pharma for failure to prevent cross-contamination and for other good manufacturing practice lapses at its drug facility in Farmingdale, N.Y. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is setting up a new board to strengthen pharmaceutical supply-chain monitoring in the wake of COVID-19-related drug shortages. Read More
The FDA’s ability to monitor drug facility compliance in fiscal year 2020 was significantly impacted by COVID-19, with only 745 inspections completed for the year vs. 1,367 in fiscal 2019. Read More
The COVID-19 pandemic has spurred the World Health Organization (WHO) to release new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics. Read More
The company said it expects to submit data to the European Medicines Agency and other international regulatory authorities in the coming days. Read More
It’s far from clear that the government will be ready to begin giving approved booster shots to the public if the agency approval doesn’t come until Sept. 17. Read More