The FDA is implementing this major new legislation, which includes important provisions regarding patient access to experimental drugs and medical devices, information on clinical trials, pharmacy compounding, food safety and labeling, and other matters. One provision of the act abolishes a prohibition on manufacturers' dissemination of information about unapproved uses of drugs and devices, permitting them to disseminate peer-reviewed journal articles provided that they commit to file, within a specified time frame, an application to establish the safety and effectiveness of the unapproved use. The statute also adds a new provision that will require tracking of the status of postmarketing approval studies.
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