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SCOTUS Decisions Effect on FDA Analyzed

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Six Squire Patton Boggs attorneys lay out the impact of four recent Supreme Court decisions on several aspects of FDA regulation.

Require Studies for Prednisolone Eye Drops: DifGen

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DifGen asks FDA to require long-term refrigerated stability studies for any generic form of its Prednisolone Ophthalmic Solution 1...

Workshop on Patient Experience Data

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Federal Register notice: FDA announces a 12/13 virtual public workshop entitled Patient-Focused Drug Development: Workshop to Disc...

Boston Scientific Recalls Cryoablation Catheters

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Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula r...

LivaNova Sleep Apnea Device Meets Endpoints

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LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.

FDA Needs Inspection Staff Recruitment Plan: GAO

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GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspe...

FDA Clears GEs Head-Only MRI Device

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FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.

QS Issues at American Contract

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FDA warns Mechanicsville, VA-based American Contract Systems about Quality System Regulation violations in its manufacturing of st...

CGMP Violations in Zhejiang Qimei Records Review

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FDA warns Chinas Zhejiang Qimei Cosmetic Co. about CGMP violations in its manufacturing of OTC drugs.

Abeona Skin Disorder BLA Resubmission Accepted

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FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients w...