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Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials. Read More
Eli Lilly has submitted a request for an Emergency Use Authorization (EUA) for its monoclonal antibody LY-CoV555, following new positive trial data for its antibody combo in treating COVID-19. Read More
In the U.S., the federal government said it no longer has to control the distribution process because there is a sufficient supply to treat COVID-19 patients. Read More
The European Medicines Agency (EMA) began its second expedited review of a COVID-19 vaccine candidate, starting its evaluation of data for Pfizer/BioNTech’s vaccine hopeful BNT162b2 on Tuesday. Read More
Rick Bright, the former director of NIH’s Biomedical Advanced Research and Development Authority (BARDA), has resigned from the institute, alleging that its leadership failed to assign him meaningful work and ignored his recommendations because of politics. Read More
Despite the White House reportedly blocking the FDA’s tighter requirements for COVID-19 vaccine Emergency Use Authorizations (EUAs), the agency has opted to release them. Read More
The FDA released a straight-to-final guidance on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Read More
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
Jack Garvey, founder and CEO of Compliance Architects, a firm specializing in GMP, quality and compliance services, calls for caution in applying the FDA’s new compliant-manufacturing resumption guidance.Read More
In a proposed rule, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that were modified or delayed due to COVID-19. Read More