Tag Archives: FDA
New Focus of Pharma: Risk Management Throughout the Life Cycle of a Medicine
By Jim Mittler, PhD Creating a heightened focus on drug safety early in the drug development process is becoming the new paradigm for pharmaceutical companies. After hearing risk management...
Posted in Digital Health, Social Media
Tagged drug safety, FDA, REMS, Risk mitigation
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Building an Effective Global Risk Management and Drug Safety Program
By Jim Mittler, PhD Since 2007, the FDA has had the authority to require pharmaceutical companies to develop a risk evaluation and management strategy (REMS) for marketed products to ensure that...
The FDA Adresses Social Media
By DJ Edgerton The FDAhas been begging for suggestions on how to be more transparent, which in itself was impressive - but now, they're actually doing what the industry assumed would never happen....
The FDA, Freedom of Speech and the Web
By Guy Mastrion For Pharma marketers, digital media (the web specifically) is anything but black and white. The FDA requires that all branded marketing and promotional materials be viewed within...
Posted in Social Media
Tagged Compliance, Education, FDA, Legal Issues, Pharma, social media, Web Design
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