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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
The Biden administration has pledged to pour almost $3 billion into beefing up domestic COVID-19 vaccine manufacturing as it considers a potential mass program of booster shots. Read More
The outcry over the FDA’s June 7 accelerated approval of Biogen’s Alzheimer’s drug Aduhelm gained new momentum last week as two House committees demanded more details from the FDA by Sept. 16 about the circumstances that led up the controversial decision. Read More
The FDA is deliberating between approving a booster shot of Moderna’s COVID-19 vaccine at a 50 microgram (mcg) level or at a current 100 mcg level, the latter being the level that make up the first two doses each of the vaccine. Read More