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Comments Reopened on ICH Q12 Guidance

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Federal Register notice: FDA reopens the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FD...

Info Collection on FDA Communications Testing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Tes...

FDA Rejects Lenzilumab EUA for Hospitalized Covid Patients

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FDA declines to grant emergency use authorization to Humanigens lenzilumab for treating newly-hospitalized Covid-19 patients.

FDA Breakthrough Device Designation for Novocure System

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FDA grants breakthrough device designation to Novocures TTFields system for use with two liver cancer drugs.

10 Companies Warned Over Diabetes Dietary Supplements

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FDA and the Federal Trade Commission warn 10 companies that they are illegally marketing drugs to treat diabetes as dietary supple...

Congress Must Regulate CBD Since FDA Wont: Steve Mister

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Council for Responsible Nutrition CEO Steve Mister says Congress must regulate the cannabidiol market since FDA is unwilling to.

ICU Medical Recalls Aminosyn II

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ICU Medical recalls one lot of Aminosyn II, 15% (amino acid injection) sulfite-free intravenous solution due to the presence of vi...

Robust Responses in Moderna Covid Booster

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Moderna says a Phase 2 trial shows a robust response to a third or booster shot of its Covid-19 mRNA vaccine.

Myfembree sNDA for Endometriosis Pain

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FDA accepts for review a Myovant Sciences and Pfizer supplemental NDA for Myfembree for managing moderate to severe pain associate...

Apellis Pharma Plan NDAs for Geographic Atrophy

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Apellis Pharmaceuticals says it plans to file an NDA in the first half of 2022 after reporting top-line results from the Phase 3 D...