In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following:
- Financial Disclosure by Clinical Investigators. This final guidance assists in interpreting and complying with regulations governing financial disclosure by clinical investigators. It provides FDA’s responses to the most frequently-asked questions regarding financial disclosure by clinical investigators.
- Distinguishing Medical Device Recalls from Product Enhancements: Reporting Requirements. This draft guidance clarifies when a potential change to a device is a medical device recall, distinguishes those instances from product enhancements, and identifies the reporting requirements for both recalls and product enhancements.
- Labeling for Human Prescription Drug and Biological Products: Implementing the PLR Content and Format Requirements. This final guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under the Physician Labeling Rule (PLR). It provides recommendations for applicants developing labeling for new prescription drugs and revising labeling for already approved prescription drugs.
- Providing Information about Pediatric Uses of Medical Devices under Section 515A of the Federal Food, Drug, and Cosmetic Act (FFDCA). This draft guidance describes how to compile and submit the readily-available pediatric use information required under the FFDCA.