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FDA Denies Appeal; Pepaxto to be Withdrawn

[ Price : $8.95]

FDA rejects an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approved...

FDA to Change Some Trial Registration Enforcement

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FDA says it has responded to a Universities Allied for Essential Medicines by creating a dashboard of Clinical Trials.gov pre-noti...

ClearPoint Brain Modeling Software Cleared

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FDA clears a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling.

Zimmer Robotic Shoulder System Cleared

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FDA clears a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.

Industry Faults FDA Research on DTC Implied Claims

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Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Drug Promotion research into impl...

Nearly 1,000 Generic Drugs OKd in 2023

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The CDER Office of Generic Drugs 2023 annual report details the 956 ANDAs approved or tentatively approved last year.

Election Year Will Affect FDA Actions: Attorneys

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Two Hogan Lovells attorneys and two Greenleaf Health executives discuss FDA actions in this election year at a recent J.P. Morgan ...

Breakthrough Status for Cognitive Behavioral Therapy

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FDA grants Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy platform that is intended to...

Guide on Drug/Biologic Covid Studies

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Federal Register notice: FDA makes available a final guidance entitled Assessing Covid19-Related Symptoms in Outpatient Adult and ...

McLaren Debarred by FDA for 5 Years

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Federal Register notice: FDA debars Taylor McLaren for five years from importing or offering for import any drug into the U.S.