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8 Observations on Ipca Labs FDA-483

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FDA releases the form FDA-483 issued following a June inspection at Indias Ipca Laboratories.

CRL for Amneal Parkinsons Drug

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FDA cites safety concerns in a complete response letter to Amneal Pharmaceuticals for its new formulation of Parkinsons drug carbi...

CDER Site-Selection Model MAPP

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CDER publishes a Manual of Policies and Procedures on the operation of its site selection process for routine inspections.

Federal Register Notices 7/3 to 7/10

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FDA Webview posts the Federal Register notices published during our 7/3-10 annual Independence Day break.

CDRH Moving to Electronic Export Docs

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CDRH says it is transitioning from paper export documents for medical devices to electronic export documents starting 1/2/2024.

Novartis Leqvio Gets Expanded Label

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FDA approves a labeling update for Novartis Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an i...

29-Page Intas FDA-483

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FDA releases a 29-page form FDA-483 with 16 observations from a May inspection at Indias Intas Pharmaceuticals, a manufacturer of ...

Outset Medical Gets Tablo Warning Letter

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Outset Medical says it will cooperate with FDA in an effort to resolve a 7/5 Warning Letter about its Tablo Hemodialysis System.

Sarepta Sells Priority Voucher for $102 Million

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Sarepta Therapeutics sells for $102 million its Rare Pediatric Disease Priority Review Voucher that was awarded last month.