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New York Gov. Andrew Cuomo is threatening not to distribute FDA-approved COVID-19 vaccines in his state until they receive approval from a state task force of scientists, doctors and health experts. Read More
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that White House interference with the FDA’s policies for authorizing a COVID-19 vaccine would be “troublesome.” Read More
Novavax yesterday launched a phase 3 clinical trial of its COVID-19 vaccine in the UK, becoming the latest drugmaker to bring a vaccine candidate to late-stage testing. Read More
HHS yesterday unveiled the much-anticipated final rule allowing imports of prescription drugs from Canada, delivering on a Trump Administration promise ahead of the presidential election. Read More
The European Commission’s (EC) contracts with COVID-19 vaccine suppliers include limited indemnity against liability in case of unexpected side effects, the president of a European vaccine trade group said this week. Read More
The Government Accountability Office (GAO) has proposed that the FDA’s drug evaluation, biologics evaluation and medical device centers implement formal equipment management policies after finding that their current procedures need improvement. Read More
The FDA has announced that it is requiring an update to the Boxed Warning for benzodiazepines to include the risks of abuse, physical dependence and withdrawal reactions associated with their use. Read More
Relief Therapeutics and NeuroRx have applied to the FDA for an Emergency Use Authorization (EUA) for RLF-100 (aviptadil) for the treatment of critical COVID-19 patients with respiratory failure. Read More