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Category Archives: Regulatory
Government-Funded Research: Is It That Different?
In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research.” The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases [...]
Also posted in Guest Blog, R&D, Safety Tagged Bioethics Commission, government-funded research, NIH, Regulatory Leave a comment
PCORI, Priorities, and Politics
William Looney looks at the three P’s of effectiveness research: PCORI, Priorities, and Politics
If you ever wanted to know what health economists might do with a billion dollars, the Obama Administration’s Patient-Centered Outcomes Research Institute [PCORI] is about to tell all: not right down to the penny, but good enough. The congressionally funded – [...]
Also posted in healthcare Tagged effectiveness research, Health Reform, healthcare, Patient Centered Outcomes Research Institute, PCORI Leave a comment
Genentech Runs Voluntary Corrective Ads for Boniva
Even though Roche-owned Genentech wasn’t required to run costly corrective advertisements following an FDA Untitled Letter on Boniva last January, the company has done so anyway.
Also posted in Advertising, Corporate Responsibility, FDA, Legal, Marketing, compliance, leadership Tagged DDMAC, Genentech, OPDP, Roche Leave a comment
Off-Label Comments Online: Keep Doing What You're Doing, Says FDA
Those in favor of a less is more approach to FDA social media guidelines got what they wanted for the holidays: a trim, 15-page document on how to respond to unsolicited off-label comments
Also posted in Advertising, E-Media, FDA, Legal, Marketing, Technology, compliance, social media Tagged FDA Leave a comment
Unmet Need in the Migraine Space?