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NZ Zyprexa Ad Complaint Upheld

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New Zealands Advertising Standards Authority says a Lilly booklet depicting Zyprexa success stories violated the countrys drug ad ...

Celebrity Endorsements Out in China Drug Ads

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Chinas State Food and Drug Administration bans celebrities from appearing in drug ads.

Takeda Runs Actos Safety Ads

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Takeda runs ads touting Actos safety in 82 newspapers and news magazines.

Simultaneous Voting Pushed for Advisors

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A new FDA guidance says advisory committees should use simultaneous voting to prevent problems that can be caused by sequential vo...

FDA Grants Priority Review to Abilify sNDA

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FDA grants a priority review for an Otsuka Pharmaceutical supplemental NDA for atypical antipsychotic Abilify (aripiprazole) that ...

Republicans Ask von E to Probe Device Dispute Process

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Two key Republican House oversight committee members ask FDA commissioner Andrew von Eschenbach to investigate its dispute resolut...

FDA Hears BTC Drug Support, Opposition

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Stakeholders tell FDA there are good and bad reasons to sell additional drugs from behind the counter.

FDA Places Antibiotic on Safety Scrutiny List

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FDA requests additional safety data from Bristol-Myers Squibb about its antibiotic Maxipime (cefepime) due to concerns that the dr...