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Corrections on Pediatric Cough/Cold Drug Hearing

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Federal Register Notice: FDA corrects electronic registration and contact person information on a 10/2 hearing on OTC cough and co...

Prismic Light Marketing Unapproved Drugs

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FDAs New Orleans District Office warns Prismic Light that two of its products are being marketed as unapproved drugs and cannot be...

FDA Refuse to File Letter on Introgen BLA

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FDA issues a refuse to file letter to Introgen Therapeutics for its BLA Advexin, indicated for treating recurrent, refractory squa...

Kirkman-Campbell Debarred

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Federal Register Notice: FDA issues an order permanently debarring Maria Anne Kirkman-Campbell.

Heart Patient Replaces Celebrity Jarvik in New Lipitor Ads

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Pfizer replaces Robert Jarvik in Lipitor ads with a real Lipitor patient.

FDA Cites Foods Web Site For Drug Claims

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FDAs Atlanta District Office says New Life Foods Web sites are promoting three products as unapproved drugs.

CDRH Names New Post-market Associate Director

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FDA selects Clinilabs chief medical officer Jonathan Sackner-Berstein as CDRHs new associate director for post-market operations e...

Convicted Ketek Investigator Finally Debarred

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FDA debars convicted Ketek (Sanofi-Aventis) clinical investigator Anne Kirkman-Campbell, four years after her conviction for submi...

Enzyte Sentence Likely Not Typical

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Attorneys Ricardo Carvajal and J.P. Ellison say fraud loss, more than unsubstantiated dietary supplement claims, affected the heav...

FTC Sets Generic Biologics Patent Workshop

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The Federal Trade Commission poses questions for public response relating to potential marketing exclusivity for follow-on biologi...