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Cardiologist Sends Affidavit to Hahn

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Wisconsin cardiologist Nalini Rajamannan contacts FDA commissioner Stephen Hahn over the agencys decision not to provide informati...

2 Drug Interaction Guidances Out

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FDA publishes two guidances describing a systematic system for evaluating drug-drug interactions and communicating about them in l...

AbbVie Seeking New Orilissa Indication

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The Philadelphia Inquirer reports that FDA is expected to rule later this year on a proposed new indication to treat uterine fibro...

Dietary Supplements Recalled Over GMP Inspection

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ABH Nature's, ABH Pharma and Stocknutra.com recalls its dietary supplement products manufactured and sold between 1/2013 to 11/201...

Baze At-home Blood Nutrient Test Cleared

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FDA clears a Baze 510(k) for its at-home blood collection process and its use to assess blood nutrient status.

Medtronic Gets OK for PulseSelect Ablation Trial

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FDA gives Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of its PulseSelect ...

Animal User Fee Reporting Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension for Reporting Associated With Animal Drug and A...

Info Collection on Electronic Product Radiation

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Federal Register notice: FDA seeks comments on an information collection extension for Electronic Products 21 CFR Parts 1000 Thro...

Cardene Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Chiesi USAs Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withd...

BsUFA User Fee Assessment Guidance

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FDA publishes a guidance on changes in the Biosimilar User Fee program.