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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...

Nominations Sought for Tobacco Committee

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Federal Register Notice: FDA requests nominations for voting members for the Tobacco Products Scientific Advisory Committee.

FDA Fast Track for ALS Cell Therapy

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FDA grants BrainStorm Cell Therapeutics a fast track designation for NurOwn for treating amyotrophic lateral sclerosis.

Takeda Sues FDA, HHS Over Mitigare Approval

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Takeda asks the DC federal court to order FDA to rescind or stay its approval of a Hikma 505(b)(2) application for Mitigare.

CareFusion 203 Recalls Ventilators

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FDA says CareFusion 203 Inc. is recalling three ventilator models that can experience a loss of power.