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Several drugmakers have offered suggestions in written comments to the FDA for revisions to the agency’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube.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
The Biden administration’s plan for a Sept. 20 rollout of vaccine booster shots may be delayed as the FDA and the Centers for Disease Control and Prevention (CDC) consider the available data for the Pfizer/BioNTech, Moderna and Johnson & Johnson (J&J) boosters. Read More
The FDA is getting back its rulemaking authority, which was significantly weakened under President Trump, as the Biden administration reverses multiple policies from the previous administration. Read More