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Archive for the ‘ FDA Files ’ Category

Higher standard set for risk presentation

Wednesday, June 10th, 2009

Recently, FDA issued a draft guidance titled Presenting Risk Information in Prescription Drug and Medical Device Promotion. The draft guidance outlines factors FDA considers when evaluating ads and labeling for prescription drugs, providing examples to illustrate the agency’s thinking. According to FDA, the guidance was issued in response to requests ...

New FDA guidance offers risks/rewards for industry

Tuesday, January 20th, 2009

Earlier this month, FDA issued a final guidance on Good Reprint Practices, which will make it easier for pharmaceutical companies to advise doctors on unapproved uses of medicines.  The guidance sets out FDA's new thinking when it comes to the distribution of medical journal articles and scientific or medical reference ...