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Bausch Hit With OPDP Letter on Duobrii

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CDERs Office of Prescription Drug Promotion issues Bausch Health Companies an untitled letter that cited the firm over its promoti...

Grassley, Warren Bill to Speed OTC Hearing Aid

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A bill introduced by Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) pressures FDA to issue its final rule within 30 days ...

Medicare Coverage for Aduhelm Only in Studies

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In a significant blow to Biogens controversial accelerated approval of Aduhelm (aducanumab), CMS says Medicare will cover traditio...

FDA OKs Janssen Longer Vaccine Shelf Life

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FDA authorizes a two-month shelf life extension for Janssens refrigerated Covid-19 vaccine.

Humanitarian Use Devices Info Collection Comments

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Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Humanitarian Use Devic...

Whole Slide Imaging in Tox Studies

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FDA publishes a draft guidance in question-and-answer format on using whole slide images in nonclinical toxicology studies.

Califf Plan to Improve Healthcare Outcomes, Equity

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FDA commissioner Robert Califf lays out a six-step plan to better leverage health technology, data, and capabilities to improve he...

ORA Shares MRA Experience During Pandemic

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FDA associate commissioner for regulatory affairs Judith McMeekin shares ORAs experience during the pandemic about relying on insp...

Former Pharmatech CEO Charged

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The Justice Department says the former CEO of Floridas Pharmatech has been indicted in connection with a 2016 inspection that foun...

Device Cybersecurity Quality Guidance Updated

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FDA publishes an updated draft guidance on aspects of medical device cybersecurity.