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FDA-483 Not a Proxy for Overall Quality: Califf

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Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should c...

CGMP Deviations in Henan Lvyuan Inspection

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FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing prac...

Modernize DTC Ads with QR Code: WLF

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A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize t...

NIH-Funded Study to Assess GLP-1 Drugs in Alzheimers

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Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs co...

FDA Says Proposed Drug Import Guidance Unwarranted

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FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alternative funding programs.

Mitapivat Moving Toward Accelerated Approval in Sickle Cell: Agios

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Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission ...

FDA Warns of Serious Liver Risks Linked to Tavneos

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FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk o...

FDA Seeking Input on Expanding Digital Health Tech in Trials

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Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health...

Scholar Rock Refiles BLA for Spinal Muscular Atrophy Therapy

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Scholar Rock resubmits its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy.

Novel CAR-T Therapy Gets Breakthrough Status

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A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receive...