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FDA Sends Info on Device Third Party Review to OMB

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Federal Register Notice: FDA sends a proposed collection of information on device third party review to the Office of Management a...

FDA Sends Info on Human Tissue to OMB

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Federal Register Notice: FDA submits a proposed collection of information on human tissue intended for transplantation to the Offi...

Guidance on Compounding Reporting

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Federal Register Notice: FDA releases a draft guidance: Interim Product Reporting for Human Drug Compounding Outsourcing Facilitie...

Guidance on Registration for Compounding Outsourcing Facilities

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Federal Register Notice: FDA releases a draft guidance: Registration for Human Drug Compounding Outsourcing Facilities Under Secti...

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...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Allergy Laboratories, Blueshine/Hyperion Medical, Shoney Scientific India, Synec...