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Ang. Chem. Gets Weirder Every Day

Thursday, May 20th, 2010

The fine people at Angewandte Chemie ‘s English edition, who continue to have way too much time on their hands, appear to have declared this 70s and 80s music month. So far I’ve spotted The Beach Boys , Toni Basil (a particularly strained one), and Elvis Costello . There are movies , too here’s another James Bond reference – but if anyone can tell me where the “Beverley Hills” part comes into this one , other than the desire to reach for a joke, I’d be grateful.

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FDA Blasts Lilly’s PAH eCommunity Videos!

Monday, February 8th, 2010

In a Notice of Violation letter to Lilly ( see here ), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly’s drug approved for the treatment of Pulmonary Arterial Hypertension (PAH). The patient videos present statements made by Adcirca users, “Traci” and “Carolyn” who make the following claims among others: “I can walk, and stairs don’t bother me after Adcirca treatment

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Adcica (Cialis) gets a letter from the FDA for omitting key risk information

Thursday, February 4th, 2010

Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. Although the web page presents the most common side effects associated with Adcirca, it fails to include any of the Contraindications or Warnings and Precautions information for this drug product .

Posted in: DTC, Regulatory | 0 Comments »

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Adcica (Cialis) letter from the FDA

Thursday, February 4th, 2010

Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. Although the web page presents the most common side effects associated with Adcirca, it fails to include any of the Contraindications or Warnings and Precautions information for this drug product

Posted in: DTC | 0 Comments »

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