Monthly Archives: August 2009

Feds Chase Down Faulty Skincare Promos

By George Koroneos | Published: August 26, 2009
FDA’s Division of Drug Marketing Communications, this week, posted a slew of warning and untitled letters to pharma firms for misleading skincare advertisements. Johnson & Johnson, Galderma, and Allergan each received a letter documenting complaints ranging from false advertising to unsubstantial efficacy claims. J&J received a violation letter in response to a journal ad for its [...]
Posted in FDA, Marketing | Tagged , , , , | 2 Comments

Pfizer to Launch Clinical Trial Network

By George Koroneos | Published: August 26, 2009
Image via Wikipedia Pfizer announced, last week, that it was partnering with technology firm Private Access to launch an online social network to help patients find clinical trials more easily. According to Pfizer, a top complaint from physicians is difficulty in matching patients with trials. “Finding volunteers has been a big issue for anyone conducting a clinical [...]
Posted in E-Media | Tagged , , , , , , | 5 Comments

FDA Readies More Warning Letters, Fast Enforcement Action

By Jill Wechsler | Published: August 26, 2009
Image by Getty Images via Daylife FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too many [...]
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Will Healthcare Reform Pay Off?

By George Koroneos | Published: August 20, 2009
Written by Jordan Melnick Members of Congress are in for a hard landing when they get back from recess in early September. After four weeks at home in their districts, the debate will heat up again as they resume the arduous process of crafting the biggest piece of President Obama’s domestic agenda. With the president demanding [...]
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Adverse Event Reports Go Digital Only

By George Koroneos | Published: August 20, 2009
Image via Wikipedia FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions. “This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information with [...]
Posted in Regulatory, Safety | Tagged , , , , , | 1 Comment