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Panel to Discuss Anthrax and Gardasil Vaccines

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/16-17 will meet to discuss ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Activa Brand, CVS, Enriching Gifts, Healex, Johnson & Johnson, M.I. Tech, Neoven...

FDA Warns Companies on Mouth Rinse Claims

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FDA warns three companies that they are making unproven plaque-removal claims for their mouthwash products containing sodium fluor...

Neglect of FDA Culture Defects Creates Other Issues

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Washington commentator Robert F. Steeves finds more extreme delays in FDAs responses to public petitions and attributes them to le...

Ex-FDAer Waxler, Eye Surgeon Spar on CNN Over LASIK

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Former CDRH chief of ophthalmic devices Morris Waxler battles leading LASIK surgeon Stephen Slade on CNN about whether the controv...

HHS Again Looking at FDA Scanner Approvals

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The Associated Press reports that the HHS inspector general is looking into CDRH managerial misconduct in pressuring device review...

Zibotentan Prostate Cancer Trial Fails

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AstraZeneca says a Phase 3 trial of its zibotentan in men with metastatic castration-resistant prostate cancer did not meet its pr...

FDA to Surgeons: Check for Micro Clip Sterility

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FDA says hospital staff need to be aware that some devices in a manufacturers line may be sterile while other products are not.

Info Supplement GMPs Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on cGMPs for dietary supplements to the Office of Manageme...

Stakeholders Want FDA Approval of All Patient Info

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Dismissing an FDA proposal to limit its review and approval of patient medication information, stakeholders urge the agency during...