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FDA Continuing with Aggressive Inspections of Drug Compounders

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In the wake of a new law on regulating pharmacy drug compounding, FDA says it intends to continue proactive and for cause inspecti...

Guidance on Penalties for Tobacco Retailers

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Federal Register Notice: FDA releases a guidance, Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Quest...

FDA Withdraws Proposed Compounding List

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Federal Register Withdrawal of proposed rule: FDA withdraws a proposed rule that would list bulk drug substances for pharmacy comp...

FDA Clears Aura Spinal Fusion System

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FDA clears an Aurora Spine 510(k) for its ZIP Minimally Invasive Interspinous Fusion System for spinal fusion.

FDA OKs California Stem Cell Phase 3 Trial in Melanoma

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FDA approves a California Stem Cell Phase 3 clinical trial of its DC-TC therapy using cancer stem cells from a resected tumor samp...

Draft Guidance on BE Studies for Some ANDAs

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FDA issues a draft guidance on bioequivalence studies for certain ANDAs and supplements.

FDA Says Tris Pharma Not Complying with PREA for Nexiclon

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FDA says Tris Pharma has failed to comply with pediatric assessment requirements for its Nexiclon.

Orphan Status for Kinex Brain Cancer Drug

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FDA grants Kinex Pharmaceuticals an orphan drug designation for KX02 for treating gliomas.

FDA Releases Info on 9 Safety Evaluations

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FDA releases its postmarket safety evaluations on nine drugs completed earlier this year.

FDA Releases Meridian Medical Inspection Report

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FDA releases the FDA-483 from a March-April inspection at Meridian Medical Technologies.