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Viz.ai Algorithm Cleared for Abdominal Aneurysms

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FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic ane...

Regulatory Review Period for Esperoct

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Esperoct (ant...

Device Regs Amended to Correct Errors

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Federal Register notice: FDA amends certain medical device regulations to update mailing addresses and docket numbers.

Sandoz sBLA for Citrate-free Hyrimoz

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FDA approves a Sandoz supplemental BLA for citrate-free Hyrimoz (adalimumab-adaz) injection, a biosimilar version of Abbvies Humir...

ICH Approves Gene Therapy S12 Guidance

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The International Council for Harmonization approves the S12 guidance on nonclinical biodistribution studies for gene therapy prod...

Changes Suggested for Cancer Drug Dosing Guidance

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The Friends of Cancer Research suggests possible additions to an FDA draft guidance on optimizing the dosage of oncologic drugs.

Significant CGMP Violations at Dunagin Pharmaceuticals

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FDA warns Rogers, AR-based Dunagin Pharmaceuticals, which does business as Massco Dental, about CGMP violations in its manufacturi...

Multiple Violations at Contract Manufacturer

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FDA warns Torrance, CA-based Cosmetic Science Laboratories about CGMP and other violations in its production of finished drugs as ...

Turn Gene Therapy into Reality: Marks

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CBER director Peter Marks tells a Muscular Dystrophy Association conference about ways FDA is addressing barriers to developing ge...

CDERs Requests for Intarcia Hearing

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CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/...