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Draft Guidance on Determining When REMS is Necessary

[ Price : $8.95]

Federal Register Notice: FDA posts a draft guidance entitled FDAs Application of Statutory Factors in Determining When a REMS Is N...

House Committee Leaders Want OCI Update

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Leaders of the House Energy and Commerce Committee ask FDA for extensive updated information on the agency Office of Criminal Inve...

Adverse Events Unreported in Published Studies: Research

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Researchers say they found that a significant amount of adverse event data is not reported in published reports of clinical trials...

FDA Clears K2M Groups Spinal Screws/Connectors

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FDA clears a K2M Group Holdings 510(k) for screw and connector components for a spine application used with its MESA Spinal System...

Draft Guide on Coordinated Antimicrobial Drug/Test Development

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Federal Register Notice: FDA announces the availability of a draft guidance entitled Coordinated Development of Antimicrobial Drug...

Guidance on Reporting Device Studies on Computational Modeling

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Federal Register Notice: FDA releases a guidance entitled Reporting of Computational Modeling Studies in Medical Device Submission...

FDA Posts Revised Listing of Device Consensus Standards

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Federal Register Notice: FDA announces a publication containing modifications to the agencys list of standards it recognizes for u...

Janssens Invokamet Approved for New Indication

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FDA approves a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-lin...

Groups Fear Weakened REMS

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The 16 member organizations of the Patients Alliance for Drug Safety Protections caution that proposed legislation could weaken FD...

Armenpharm ANDA Withdrawn for Safety/Effectiveness

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Federal Register Notice: FDA suspends approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous v...