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FDORA Requires Trial Diversity Action Plans: Attorneys

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Two Hyman, Phelps & McNamara attorneys describe requirements in the new Food and Drug Omnibus Reform Act to improve clinical trial...

New CBD Regulatory Framework Needed: Woodcock

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FDA principal deputy commissioner Janet Woodcock says the agency will work with Congress to develop a new cross-agency regulatory ...

Oncology Panel to Discuss Polivy sBLA for Lymphoma

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Federal Register notice: FDA announces a 3/9 Oncologic Drugs Advisory Committee meeting to discuss a supplemental BLA for Genentec...

Oncologist Debarred for Distributing Canadian Drugs

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Federal Register notice: FDA issues a three-year debarment order against Poornanand Palaparty for receiving and distributing presc...

Biological Therapies Need Clinical Trials: Califf, Marks

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FDA commissioner Robert Califf and CBER director Peter Marks explain why biological therapies should be tested in randomized contr...

Include all Media in Drug Promotion Regs: Professors

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Two professors call for updates to the FDA system for regulating drug promotion to account for new businesses that are promoting d...

CDRH OKd 19 Breakthrough Devices in 2022

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The CDRH 2022 annual report says the Center responded to many unique and important issues.

AstraZenecas Evusheld No Longer OK for Emergency Use

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FDA says AstraZenecas Evusheld is no longer authorized for emergency use to fight Covid-19 infections.

Emergent Recalls Skin Decontamination Lotion

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Emergent recalls certain Reactive Skin Decontamination Lotion kits from a specific batch based on customer complaints about leakag...

Dental Practices Defrauded FDA: Justice Dept.

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The U.S. Justice Department charges 12 dental practice owners and co-conspirators with defrauding FDA, Medicaid, U.S. Immigration ...