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2 Medical Device Proposed Rules Scrapped

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Federal Register notice: FDA withdraws two proposed medical device rules after determining that they are not currently considered ...

Improve FDA Cybersecurity Risk Policies, Procedures: OIG

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The HHS Inspector General recommends ways FDA can improve its policies and procedures to address medical device postmarket cyberse...

FDA Looking at Balloon Pump Shutdowns

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FDA says it is evaluating over 75 reports of battery shutdown and other issues with Maquet/Datascope intra-aortic balloon pumps.

FDA Clears OsteoRemedies Spectrum GV Hip Spacer

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FDA clears an OsteoRemedies 510(k) for the Remedy Spectrum GV Hip Spacer System and Spectrum GV Bone Cement, which are intended to...

Heron Therapeutics NDA for HTX-011

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Heron Therapeutics files an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a ...

Cell Phone Safety Limits Remain Acceptable: Shuren

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CDRH director Jeffrey Shuren says current cell phone radiofrequency exposure limits are acceptable to protect the public health.

Number of FDA Port of Entry Agents Up

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FDA outlines for the House Energy and Commerce Committee its staffing levels of Port of Entry special agents tasked with stopping ...

FDA Speeding Drug Approvals: Pitts

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Former FDAer Peter Pitts praises agency efforts to speed approval of generic and branded drugs.

FDA Science Advisory Board Meeting 12/4-5

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Federal Register notice: FDA announces a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Res...

Implantable Orthopedic Device Reprocessing Petition

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A University of Toledo professor says FDA should stop clearing or approving reprocessing of pedicle screws and other implantable o...