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Medwatch Information Collection Revised on eSubmissions

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Federal Register notice: FDA sends to OMB and information collection revision entitled MedWatch: The FDA Safety Information and Ad...

5 Indicted for Prescription Drug Smuggling

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Five persons are indicted on federal charges of conspiracy to smuggle prescription drugs and money laundering conspiracy.

Guide on CAR T Cell Product Development

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Chimeric Antigen Rece...

FDA Lifts Clinical Holds on Aprea Trials

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FDA lifts clinical holds on Aprea Therapeutics clinical trials involving eprenetapopt in combination with azacitidine in myeloid m...

FDA Clears Breast Thermography Device

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FDA clears a Niramai Health Analytix 510(k) for its SMILE-100 System, a breast thermography device that is intended to help health...

Biogen Says Data Show Aduhelm Working Over 2 Years

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Biogen releases data it says demonstrate the long-term value of its Aduhelm as an Alzheimers disease treatment.

PhRMA Not Responsive on Drug Price Questions: Letter

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Members of the House and Senate say PhRMA provided them with misleading information about the role of drug manufacturers in Januar...

FDA FY 2022 OTC Monograph User Fee Rates

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Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 20...

FDA OKs Rinvoq in Ulcerative Colitis

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FDA approves an AbbVie supplemental NDA for Rinvoq (upadacitinib) for treating certain adults with moderately to severely active u...

CGMP Violations at Accu Bio-Chem Lab

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FDA warns Glendale, CA-based Accu Bio-Chem Laboratories about CGMP violations in its work as a contract testing laboratory.