FDA officials describe how the Covid-19 pandemic led to quicker and greater acceptance of real-world data/evidence.
FDA issues a revised draft guidance on covariate adjustment in some drug and biologic clinical trials.
FDA issues a draft guidance responding to additional questions about FDA-1572.
Federal Register notice: FDA makes available a final guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to...
FDA issues a guidance with its recommendations on testing to assess medical device safety and compatibility in the magnetic resonance environment.
FDA says the impact of Covid-19 on companies will result in a two-year extension of enforcement discretion of the regulation prohibiting the use of le...
Federal Register notice: FDA posts a draft guidance on Feasibility Clinical Studies for Glycemic Control devices.
Federal Register notice: FDA releases a final guidance that discusses non-clinical testing and clinical considerations for implanted brain-computer in...