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CGMP Violations at Yahon Enterprise

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FDA warns Vietnams Yahon Enterprise about CGMP violations in its manufacturing of finished drugs.

Hikma Recalls Acetaminophen Lot Over Mix-up

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Hikma Pharmaceuticals extends a Class 1 recall of one lot of acetaminophen injection, 1,000mg/100mL due to the potential presence ...

Comment Period Extended on FDA IT Strategy

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Federal Register notice: FDA extends the comment period on its 6/26-released Information Technology (IT) Strategy and Customer Exp...

OMB OKs Quantitative Claims Survey for DTC Ads

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Federal Register notice: FDA announces that OMB has approved an information collection entitled Survey on Quantitative Claims in D...

Input on Non-Device Software Functions

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Three stakeholders provide requested input to FDA on the risks and benefits of non-device software functions.

Brassica Pharma CGMP Violations

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FDA warns Indias Brassica Pharma about CGMP violations in its production of finished drugs at a facility in Thane, India.

QS Issues in Criticare Inspection

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FDA warns Criticare Technologies about QS violations in its manufacturing of patient monitors at a medical device facility in Warw...

FDA Posts Laboratory-Developed Test FAQs

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FDA posts answers to frequently asked questions about its new laboratory-developed test final rule.

Merck Touts Clesrovimab Data in RSV

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Merck reports positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab in treating respira...

Group Outlines Considerations for OS Analyses

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Experts from FDA and two other groups publish considerations for the use of overall survival as an endpoint in cancer clinical tri...