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Thermo Fisher Plant Scrutinized by FDA: Reuters

[ Price : $8.95]

A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug...

CDRH Portal Update Tracks PMA Submissions

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FDA updates CDRHs Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination...

Drug-Drug Interaction Assessments Lacking: FDA Research

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FDA says that 22% of new molecular entities required postmarketing requirements or postmarketing commitments to address knowledge ...

J&J Discontinues Dengue Virus Antiviral Development

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Johnson & Johnson discontinues a Phase 2 study evaluating mosnodenvir for preventing dengue virus in adults aged 18-65 years.

Tirzepatide Shortage Resolved, FDA Says

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FDA says the shortage of Lillys Mounjaro and Zepbound has been resolved but other similar products remain in short supply.

FDA Lifts Hold on Myotonic Dystrophy Drug

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FDA lifts a partial clinical hold on Avidity Biosciences delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for...

5 Observations on BSO FDA-483

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FDA has released the form FDA-483 with five observations from an inspection at the Lakewood, CO-based BSO outsourcing facility.

18 Potential Signals of Serious Risks/New Safety Info

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FDA releases a list of 18 drug products for which there was a potential signal of serious risks or new safety information in the s...

Breakthrough Status for Bone Regeneration Product

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FDA grants Amphix Bio a breakthrough device designation for its drug-device combination product for bone regeneration.

Opdivo Approved for Resectable Lung Cancer

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment o...