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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...

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...

BioLab Sciences Illegally Selling Products: FDA

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FDA warns Scottsdale, AZ-based BioLab Sciences it is illegally marketing drug and biologic products that have been produced with s...

FDA Reviewers Question Spectrums Pozenveo

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FDA medical reviewers tell the Oncologic Drugs Advisory Committee there are significant questions about Spectrum Pharmaceuticals p...

Agency Questions Confirmatory Study for Pepaxto

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FDA reviewers say that a confirmatory trial has not confirmed the clinical benefit of Oncopeptides Pepaxto (melphalan flufenamide)...

Comments on FDA Draft RTOR Guidance

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The Alliance for Regenerative Medicine and Pfizer suggest changes to an FDA draft guidance on real-time oncology review.

Year-One Report on the Generic Drug Cluster

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CDER Office of Generic Drugs associate director Sarah Ibrahim discusses the first-year output of the new Generic Drug Cluster invo...

Cybersecurity Alert on Medtronic MiniMed Pump

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FDA issues a safety alert on a cybersecurity risk with Medtronics MiniMed 600 Series Insulin Pump System (e.g., MiniMed 630G and M...

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...