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Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancies: Regulatory Considerations for Use...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Developing Targeted Therapies in Low-Frequency Molecular Su...[ Price : $8.95]
FDA warns California doctor Ignatius Godoy about violations in his role as clinical investigator in a pediatric flu vaccine study.[ Price : $8.95]
CDRH participates in a Kidney Health Initiative workgroup to explain regulatory considerations for central venous catheters for he...[ Price : $8.95]
FDA asks for comments on proposed research looking at how consumers respond to disease awareness communications that accompany tel...[ Price : $8.95]
FDA issues a draft guidance with recommendations for how companies can present quantitative efficacy and risk information in DTC h...[ Price : $8.95]
FDA approves Pfizers Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor for certain patients with locally advanced o...[ Price : $8.95]
FDA outlines a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent wit...