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CGMP, Other Violations at PureChemPros

[ Price : $8.95]

FDA warns Tempe, AZ-based PureChemPros it is illegally manufacturing and distributing unapproved and misbranded new drugs that vio...

FDA Information Technology Plan

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Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.

Breakthrough for Parkinsons Neurostimulator

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FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as...

Drug Use-Related Software Guide

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Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related...

Kimera Labs Illegally Marketing Exosomes: FDA

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FDA warns Miramar, FL-based Kimera Labs about illegally manufacturing and distributing unapproved exosome products that have CGMP ...

CDRH International Harmonization Plan

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FDA publishes a draft CDRH strategic plan for medical device international harmonization.

More 510(k) Changes Likely: Attorneys

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Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to...

Guide on Drug Substantial Evidence

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Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based o...

FDA Converts ASCA from Pilot to Permanent

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FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.

Houston Man Sentenced in Counterfeit Drugs Case

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A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit d...