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FDA Rare Disease Evidence Principles

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CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review...

CBER Raising Bar on Future Covid Vaccines

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Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination...

FDA Accepts NDA for Smoking Cessation Drug

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FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to q...

AI Can Cut Drug Development Costs, Time: Experts

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Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in ...

Shanghai Henlius Prolia and Xgeva Biosimilars OKd

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FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related ...

Merck PCSK9 Inhibitor Meets Trial Goals

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Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.

4 Observations in AnazaoHealth Inspection

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FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facili...

FDAs Political Turn Risks Its Core Mission: Expert

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FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by ...

Wisconsin Pharmacal CGMP Violations

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FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.

FDA Waives Efficacy Studies for Stelara Biosimilar

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FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy s...