An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.
Federal Register notice: FDA makes available a final guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmac...
FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug and biologic product ...
Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologic applications.
FDA clears a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori.
FDA says it does not expect any immediate impact on drug supplies due to tornado damage at Pfizers Rocky Mount, NC sterile drug manufacturing.
FDA posts an International Council for Harmonization-developed guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities ...
The Biden Administration threatens to veto a House spending measure that includes cuts to FDAs budget.
