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Federal Register Notice: FDA posts a draft guidance entitled FDAs Application of Statutory Factors in Determining When a REMS Is N...[ Price : $8.95]
Leaders of the House Energy and Commerce Committee ask FDA for extensive updated information on the agency Office of Criminal Inve...[ Price : $8.95]
Researchers say they found that a significant amount of adverse event data is not reported in published reports of clinical trials...[ Price : $8.95]
FDA clears a K2M Group Holdings 510(k) for screw and connector components for a spine application used with its MESA Spinal System...[ Price : $8.95]
Federal Register Notice: FDA announces the availability of a draft guidance entitled Coordinated Development of Antimicrobial Drug...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance entitled Reporting of Computational Modeling Studies in Medical Device Submission...[ Price : $8.95]
Federal Register Notice: FDA announces a publication containing modifications to the agencys list of standards it recognizes for u...[ Price : $8.95]
FDA approves a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-lin...