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Guide on GLP Study Translation

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Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.

FDA Declines to Ban Some Music in DTC Ads

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FDA declines to ban music in all DTC ads during the presentation of risk information.

Masimo Medical Watch Cleared by FDA

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FDA clears a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation and pulse rate for ove...

VAERS Has A Proven Track Record: FDA/CDC

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In a likely attempt to rebut a critical BMJ investigation, FDA and CDC officials explain, defend, and praise the Vaccine Adverse E...

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...