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3rd Eugia FDA-483 This Year So Far

[ Price : $8.95]

FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra...

Its Official: Oncopeptides Pepaxto is Withdrawn

[ Price : $8.95]

FDA posts its official notice that Oncopeptides accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has bee...

FDA Denies Generic Imodium Petition

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FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengt...

FDA Reports on Device Safety, Innovation

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CDRH releases reports on its commitment to medical device innovation and safety.

Boston Scientific Recalls Obsidio Embolic

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Boston Scientific recalls its embolic agent Obsidio Embolic after an investigation finds that its use with the aliquot technique f...

Sen. Cassidy Challenges FDA on CDS Oversight

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Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support soft...

Fresenius Recall Infusion Pump Softeware

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Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.

Lilly Filing NDA for Expanded Tirzepatide Use

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Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently mar...

Restrictions on Lutathera ANDA Sought

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Novartis asks FDA to impose limits on applications for generic forms of its Lutathera radioligand.

Sun Pharma Hit With 483 After India Inspection

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FDA issues Sun Pharmaceutical Industries a six-item Form-483 following a two-week December inspection at the firms Dadra, Dadra & ...