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Comments Sought on Drug Development Glossary

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Federal Register notice: FDA seeks comments on the agencys publication of a glossary of terms which is part of the BEST (Biomarker...

Lilly Nasal Powder Approved for Hypoglycemia

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FDA approves an Eli Lilly NDA for Baqsimi (glucagon) nasal powder, the first glucagon therapy approved for the emergency treatment...

FDA Accepts Resubmitted Brinavess NDA

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FDA accepts for review a resubmitted NDA for Correvios Brinavess to convert atrial fibrillation to sinus rhythm.

FDA Clears Life Spines Prolift Spinal Spacer

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FDA clears a Life Spine 510(k) for the Prolift Expandable Spacer System.

FDA Asks Allergan to Recall Breast Implants

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FDA says Allergan has agreed to remove from the market certain of its textured breast implant products and tissue expanders due to...

FDA Seeks BEST Resource Taxonomy Comments

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FDA solicits comments on its publication of a glossary of terms part of the BEST Resource Taxonomy.

FDA Cancels Panel Meeting on Schizophrenia NDA

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FDA cancels a 7/31 advisory committee meeting intended to review an Intra-Cellular Therapies NDA for lumateperone tosylate capsule...

Case Highlights SCOTUS Preemption Views: Attorney

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Loyola Law School professor Adam Zimmerman says a recent Supreme Court decision in an impossibility preemption case highlights spl...

Maquet Recalls Cardiac Pumps Over Battery Life

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Maquet/Datascope recalls all Intra-Aortic Balloon Pumps (IABP) due to reports about its batteries failing to hold a charge.

Samsung Bioepis Humira Biosimilar Approved

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FDA approves a Samsung Bioepis BLA for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbotts Humira.