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FDA Making Good Progress Hiring New Staff: Zeta

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Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attr...

JAMA Revisits FDA's Controversial OK of Depression Drug Gepirone

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A new analysis published in JAMA Psychiatry raises fresh questions about how FDA evaluates drug efficacy when clinical trial resul...

FDA Expands Ibrance for Breast Cancer Maintenance

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FDA grants Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy...

Drug Trial Demographic Info Reported

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FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.

Nicotine Dependence NDA Gets Complete Response Letter

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FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.

Pharmaneek Inspection Form FDA-483 Out

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FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility i...

FDA Nixes Enforcement Action Against Whoop's Blood Pressure Feature

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FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about...

Expand Real-World Evidence Use in Drug Approvals: Article

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Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.

Jubilant HollisterStier CGMP Issues

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FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.