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Shire Marketing Info Subpoenaed

[ Price : $8.95]

Shire says it is responding to an HHS Inspector General subpoena for documents on sales and marketing of its Adderall XR, Daytrana...

FDA Re-posts Un-posted P&G Warning

[ Price : $8.95]

FDA warns Procter & Gamble that it is illegally marketing DayQuil Plus Vitamin C and Nyquil Plus Vitamin C as combination drug and...

FDA Posts Q&A on Peramivir

[ Price : $8.95]

FDA posts on its Web site questions and answers on the emergency use authorization of the antiviral drug Peramivir IV for patients...

Stryker, Execs Indicted For Illegal Marketing

[ Price : $8.95]

A federal grand jury indicts Stryker Biotech and several of its executives on charges relating to alleged illegal marketing of its...

FDA Complete Response on Insomnia Drug

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FDA issues a complete response letter to Transcept Pharmaceuticals for Intermezzo (zolpidem tartrate) sublingual tablets.

FDA Amends Regs on IND Studies

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Federal Register Final rule: FDA amends its investigational new drug application regulations to direct applicants to submit INDs f...

AstraZeneca Settles Seroquel Marketing Allegations for $500 Million

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AstraZeneca says it has reached an agreement in principle with the U.S. Attorneys Office in Philadelphia to resolve investigations...

FDA Expands WebMD Consumer Info Partnership

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FDA says its partnership with WebMD is expanding to include more consumer health information.

FDAs Credibility Matters A Lot Sharfstein

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FDAs principal deputy commissioner Joshua Sharfstein tells the Alliance for a Stronger FDA that the agency is moving in the right ...

Advisors Recommend Alair System Approval

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Members of FDAs Respiratory Therapy Devices Panel vote 6-1 to recommend approval with conditions of Asthmatx Alair System bronchia...