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OIG Identifies FDA Emergency Use Authorization Issues

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FDA concurs with six recommendations made by the HHS Inspector General to improve the EUA process for tests in a future pandemic.

FDA Approves Pedmark for Cisplatin Ototoxicity

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FDA approves Fennec Pharmaceuticals Pedmark to treat cisplatin-associated ototoxicity in pediatric patients.

Panel to Discuss Zejula Supplemental NDA

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Federal Register notice: FDA announces an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplement...

FDA Approves New Contrast Agent

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FDA approves a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent for use in contrast-enha...

Catalent Hit With 12-item 483 on Moderna Vaccine

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FDA issues contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firms B...

Medtronic Cardiac Monitor Gets Expanded Use

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FDA clears a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor system for expanded use in pediatric patients over the ag...

Merck Hold Lifted to Permit New HIV Trials

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FDA lifts a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for t...

FDA Stepping Up Drug Inspections in India

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FDA says its inspections in India are nearing pre-pandemic levels.

Getting Clinical Outcome Assessments into Endpoints Guide Coming

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CDER associate director Theresa Mullin says FDA will soon release a draft guidance on Incorporating Clinical Outcome Assessments i...

Government Not Using Park Doctrine Enough: Study

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Harvard Medical School researchers call for a reinvigoration of the Park doctrine holding corporate officers personally liable for...