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NECC Owner Cadden Barred by FDA

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Federal Register notice: FDA issues an order permanently debarring Barry J. Cadden after a conviction in his role as an owner and ...

Drug Approved for Rare Forms of Obesity

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FDA approves a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management in patients six years and olde...

Pilot Program for Novel Drug Development Tools

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FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool develope...

Moderna Submits EUA for Covid-19

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Moderna submits an emergency use authorization for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vac...

Profound Medical HDE OKd for Osteoid Osteomas

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FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bo...

Guide on Drug Development Qualification Tools

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Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.

Guide on Complex ANDA Product Meetings

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Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex ...

Notifying CDRH About Device Shortage Guidance Update

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FDA updates a CDRH Covid-19 guidance on notifying the agency of medical device discontinuance or shortages.

Use 510(k) for OTC Hearing Aids: Authors

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Two hospital-based doctors call on FDA to clear OTC hearing aids using the 510(k) pathway.

CorticoMetrics AI-based Software Cleared for Radiologists

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FDA clears a CorticoMetrics 510(k) for Thinq, its artificial intelligence-based software for use by radiologists and neurologists ...