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SCOTUS Should Hear Mifepristone Appeal: FDA

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A brief filed by the U.S. Solicitor General on behalf of FDA calls on the Supreme Court to hear the agencys appeal of a 5th Circui...

Objectionable Conditions in 2 Clinical Trials

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FDA warns Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, about violations in two clinical investigations at her study...

Do Postmarket Studies Need Public Funds?: Califf

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FDA commissioner Robert Califf says there have been discussions about whether public funding should be used to support some key po...

Bayer Recalls 1 Vitrakvi Lot

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Due to concern about microbial contamination, Bayer recalls one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL gl...

Senators Want Animal Testing Info

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A bipartisan group of nine senators ask FDA what it is doing to revise its animal testing regulations to be consistent with the FD...

Chinese National Indicted Over Illegal Devices

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An eastern California federal grand jury returns a three-count indictment against a citizen of China who formerly resided in Clovi...

Complex Clinical Trial Design Workshop

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Federal Register notice: FDA announces a public workshop entitled Advancing the Use of Complex Innovative Designs in Clinical Tria...

Meeting on Drugs for Preventing Preterm Birth

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Federal Register notice: FDA announces a 1/23/24/2024 public meeting entitled Advancing Drug Development for the Prevention of Spo...

Final Rule on DTC Ad Major Statement

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Federal Register final rule: FDA posts a final rule on direct-to-consumer advertisements and a requirement that the major statemen...

GLP Report Translation Q&A Guidance

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FDA publishes a draft guidance with questions and answers on translating GLP study reports into English.