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FDA Seeks Nominations for Difficult-to-Compound Drugs

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Federal Register Notice: FDA requests nominations for specific drug products or categories to help the agency develop a list of di...

Oculus Microcyn Scar Gel Cleared by FDA

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FDA clears an Oculus Innovative Sciences 510(k) for its Microcyn Scar Management HydroGel and its use in managing old and new hype...

Consultants Say Law on Labeling Changes Should be Revised

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Cornerstone Regulatory suggests that FDA encourage changes to the laws governing safety labeling changes so it can use the Adverse...

FDA Reaches Settlement Against ASP Over Device Shelf Life

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FDA reaches a $1.25 million civil money penalty settlement against Johnson & Johnsons Advanced Sterilization Products (ASP) and tw...

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Draft Guidance on BE Studies for Some ANDAs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FDA issues a draft guidance on bioequivalence studies for certain ANDAs and supplements.