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CDRH announces new standards recognized by the agency to improve medical device sterilization.[ Price : $8.95]
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Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologi...[ Price : $8.95]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 says that a reverse-FOIA lawsuit seeking to shield an unnamed company attorneys identity in connection with a Form FDA-483 sho...[ Price : $8.95]
The 3rd Circuit Court of Appeals agrees with a Pennsylvania federal court that FDA failed to state the offense under the law in ch...