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3 CGMP Issues At Active Cosmetics Manufacturing

[ Price : $8.95]

FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.

Unetixs Vascular Selling Illegal Devices: FDA

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FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.

FDA Stresses Sponsor Responsibility in Decentralized Clinical Trials

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FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional...

Makary Defends FDA Drug Decisions

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FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agen...

CareFusion Hit With Warning at Texas Drug Facility

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FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulatio...

High Court Pauses Limits on Mifepristone

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The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill ...

Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

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An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpin...

Alnylam Pharmas Web Promo is Misleading: FDA

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FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for it...

Bayer DTC Materials Run Afoul of FDA

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FDA issues an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prosta...

Makary Outlines Sweeping Reforms to Speed Drug Development

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FDA commissioner Marty Makary outlines his goals to overhaul how the agency reviews new drugs, aiming to reduce early-stage regula...