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FDA OKs Lutonix PMA for Transluminal Angioplasty Catheter

[ Price : $8.95]

FDA approves a Lutonix PMA for its 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter, the first drug-coated b...

Final Guidance on Exclusivity Decisions for Combo Drugs

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FDA publishes a final guidance on New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.

FDA Approves Gileads New Combo Drug for Hepatitis C

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FDA approves a Gilead NDA for Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.

Amgen Success in Humira Biosimilar Phase 3 Study

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Amgen says a Phase 3 study evaluating it biosimilar candidate ABP 501 compared with Abbotts Humira (adalimumab) in patients with m...

RTI Surgical map3 Chips Allograft Violations Cited

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CBER says RTI Surgical is violating human tissue and biologic regulations in its map3 Chips Allograft.

FDA Wants More Pediatric Data on Shire ADHD Drug

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FDA tells Shire PLC that additional pediatric data would be required when it resubmits an NDA for SHP 465 (triple-bead mixed amphe...

FDA Approves Velcade Expanded Use

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FDA approves Millenniums Velcade (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma.

Guidance on Veterinary Controlled List of Terms

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Federal Register Notice: FDA releases an ICH guidance on pharmacovigilance of veterinary medicinal products and controlled list of...

Panel to Discuss NDAs for Myeloma, Iron Loss

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 11/6 to discuss a Novartis NDA for multiple myeloma and...

Advisory Board to Toxicological Research to Meet

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Federal Register Notice: FDAs Science Advisory Board to the National Center for Toxicological Research will meet 11/6-7 to hear up...