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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...

Judicial Watch Reports 16 New Deaths With Gardasil

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As part of its ongoing investigation into adverse reactions caused by Merck's human papillomavirus vaccine Gardasil, public intere...

Centocor Ortho Biotech Submits sBLA for RA Drug

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Centocor Ortho Biotech submits a supplemental BLA to FDA to expand the physician labeling for its rheumatoid arthritis drug Simpon...

Advisors Recommend Hologic Mammography System

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Members of FDAs Radiation Devices Panel recommend that Hologics Selenia breast cancer detection system is safe and effective.

Clazosertan Trial Misses Endpoint

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Trial results of Actelions clazosertain in patients with aneurysmal subarachnoid hemorrhage were not significant in favor of the d...

FTC Wants FDA Pre-approval of POM Wonderful Claims

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FTC says it wants FDA pre-approval of any future health benefit claims to be made by POM Wonderful for its pomegranate juice produ...