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Adverse Events Mount for Pradaxa, Group Says

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A drug adverse event watchdog group highlights a surge in post-marketing reports seen with Boehringer Ingelheim Pharmaceuticals's ...

Northwestern Survey Eyes Recommendations on 510(k) Revamp

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A recent Northwestern University survey serves as the basis for recommendations submitted to FDA for revamping its 510(k) clearanc...

FDA Finishes Inspection of Apicore India Plant

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FDA completes its initial inspection of Apicores API manufacturing facility in India.

Avastin Labeling Strengthened

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FDA says new risk information has been added to Avastins labeling.

Alphatec Wins 'Close-out' on 2010 Warning Letter

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Alphatec Holdings says it has resolved a 2010 Warning Letter that cited the company's Carlsbad, CA, facility over quality system r...

Advocacy Groups Want to Help Define Risk

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NORD and other patient advocates ask FDA to create opportunities for patient input on some risk/benefit deliberations.

Merck, Ariad NDA for Sarcoma Therapy

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FDA accepts for review a Merck and Ariad Pharmaceuticals NDA for ridaforolimus for treating metastatic soft-tissue or bone sarcoma...

Info on Bioequivalence Data Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on submitting bioequivalence data to the Office of Manag...

OIG to Probe REMS, Dispute Resolution, and IND Submissions

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HHS Office of Inspector General plans to pursue a number of FDA-related investigations in FY 2012, including a review of the agenc...

Ex-Synthes Execs Sentencing Next Month

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A federal court sets sentencing for four former Synthes executives, each of whom pleaded guilty to a misdemeanor charge stemming f...