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Medical Devices

LivaNova Again Recalls LifeSPARC Controller Over Software

LivaNova (TandemLife) recalls its LifeSPARC Controller due to a problematic software update that was designed to address a previous software malfuncti...

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Federal Register

FDA History Office Now Under Office of Operations

Federal Register notice: FDAs Office of Operations (OO), Office of Enterprise Management Services (OEMS) modifies its organizational structure to add ...

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Human Drugs

Lilly Gets Accelerated Approval for Lymophoma Drug

FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) for treating certain relapsed or refractory mantle cell lymphoma patients.

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Human Drugs

Rep. Guthrie to Chair FDA Oversight Committee

House leaders tap Representative Brett Guthrie (R-KY) to serve as chair of the House Energy and Commerce Committees Health Subcommittee, which oversee...

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FDA General

FDORA Requires Trial Diversity Action Plans: Attorneys

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

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Human Drugs

New CBD Regulatory Framework Needed: Woodcock

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

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Federal Register

Oncology Panel to Discuss Polivy sBLA for Lymphoma

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

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Federal Register

Oncologist Debarred for Distributing Canadian Drugs

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

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Biologics

Biological Therapies Need Clinical Trials: Califf, Marks

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

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Marketing

Include all Media in Drug Promotion Regs: Professors

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