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Almost 3,000 Establishment Inspections in FY 2023

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The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type an...

Philips Updates Ventilator Instructions

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FDA says a 4/1 Philips Respironics recall revising the use instructions for its OmniLab Advanced+ ventilator is Class 1.

Subtle Medical Imaging Software Cleared

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FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recover...

Rare Pediatric Disease Status for Leukemia Drug

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FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treati...

Priority Voucher Used for Vyvgart Hytrulo sNDA

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Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyeli...

GMP Violations in YangZhou Records Review

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FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.

CGMP Violations at Jiangsu Hengrui

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FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs

Combination Product Application User Fees

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FDA publishes a guidance on how it calculates combination product application user fees.

FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug

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FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy fo...

Guidance on Pediatric IBD Drug Development

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FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.