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An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) I...[ Price : $8.95]
FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug a...[ Price : $8.95]
Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologi...[ Price : $8.95]
FDA clears a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori.[ Price : $8.95]
FDA clears a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medi...[ Price : $8.95]
FDA says it does not expect any immediate impact on drug supplies due to tornado damage at Pfizers Rocky Mount, NC sterile drug ma...[ Price : $8.95]
FDA posts an International Council for Harmonization-developed guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mu...