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Import Safety Framework Relies on Increased Cooperation

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A new HHS report on import safety says FDA and other agencies will need to increase their cooperation with foreign governments, fo...

MedWatch Warning on Pfizers Viracept

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Pfizer warns healthcare professionals about increased levels of ethyl methanesulfonate present in its HIV therapy Viracept, which ...

King Reports Avinza Patent Challenge

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King Pharmaceuticals says Iceland-based Actavis has filed an ANDA with a Paragraph 4 certification challenging a utility patent on...

FDA Gives Orphan Status to Metabasis Cancer Drug

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FDA gives orphan drug status to Metabasis liver cancer drug candidate MBO7133.

WLF Says DTC Tax Bill Unconstitutional

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Attorneys Arnold Friede and John Kamp say Rep. Pete Starks bill to ban tax deductions for some DTC advertising is unconstitutional...

Frova Action Date Delayed

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FDA says it will issue an action letter 9/30 on Endo and Verrnalis sNDA for an expanded indication for Frova for short-term preven...

Drug Companies, White House Lose on Patent Bill

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The House passes patent reform legislation opposed by drug companies and the White House.

Reported Deaths from Drugs Jump Over 270%: Study

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A new study in the Archives of Internal Medicine finds that reported deaths associated with drug adverse events more than doubled ...

Merck Adds Birth Defects Precaution to Singulair Label

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Merck adds a new precautions statement about birth defects to its asthma drug Singulair.

Researchers Say Animal Studies Not Useful

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Researchers question the value of some animal studies to human health.