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Federal Register

FDA Seeks Nonvoting Device Panel Members

Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representatives to serve on cert...

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Federal Register

FDA Terminating Winnes Debarment

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

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Biologics

Panel Backs Sickle Cell Gene Therapy Safety

FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assessments on their sickl...

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Human Drugs

FDA Expects Increasing Cannabis Research

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

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Human Drugs

Unlicensed Wholesaler Sentenced to Prison

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

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Human Drugs

Tonix Shuts Down Depression Drug Development

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

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Human Drugs

New FDA Off-Label Guide Has Challenges: Lawyers

Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications between companies and ...

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Human Drugs

FDA Sends 8-item 483 to NATCO Pharma

FDA issues NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firms Telangana, India, manufacturing facility 10/18.

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Medical Devices

Multiple Violations at WAVi Co.

FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unapproved, adulterated, a...

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Human Drugs

Stakeholders Views on FRAME

FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.