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FDA Denies Novartis Entresto Petition

[ Price : $8.95]

FDA denies a Novartis 2022 petition seeking specific agency actions on ANDAs citing Entresto as the reference-listed drug.

Telix NDA for PSMA-PET Imaging Kit

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FDA accepts for filing a Telix Pharmaceuticals NDA for TLX007-CDx, a proprietary cold kit for preparing prostate-specific membrane...

Guide on OTC Monograph eSubmissions

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FDA posts a final guidance entitled Providing Over-the-Counter Monograph Submissions in Electronic Format.

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...