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Why Are FDA-483 Observations the Same?

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Former FDAer Steve Lynn asks what the drug industry and regulators can do working together to break the cycle of more than 20 year...

FDA Seeks Nonvoting Device Panel Members

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Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representati...

FDA Terminating Winnes Debarment

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Federal Register notice: FDA grants a special termination of the debarment of David Winne due to his cooperation with federal offi...

Panel Backs Sickle Cell Gene Therapy Safety

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FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assess...

FDA Expects Increasing Cannabis Research

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An FDA post reviews 50 years of agency involvement in cannabis research and predicts the increase seen in recent years will contin...

Unlicensed Wholesaler Sentenced to Prison

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A Florida federal judge sentences Marina Sievert to two years in federal prison for mail fraud and introducing into interstate com...

Tonix Shuts Down Depression Drug Development

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Tonix Pharmaceuticals discontinues the development program for major depressive disorder candidate TNX-601 ER based on disappointi...

New FDA Off-Label Guide Has Challenges: Lawyers

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Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications be...

FDA Sends 8-item 483 to NATCO Pharma

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FDA issues NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firms Telangana, India, manufacturing fac...

API CGMP Deviations at Ali Pharmaceutical

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FDA warns Omaha, NE-based Ali Pharmaceutical Manufacturing about significant CGMP deviations for active pharmaceutical ingredients...