Activities have included development and administration of a program to study patient outcomes, development of clinical guidelines and evidence based practice centers, and support of the development of quality measures. The appropriate use of medical therapies, such as drugs, biologics and devices is critical to effective, high quality, affordable health care. The Centers for Education and Research on Therapeutics will seek to make more information available after marketing to fill the gap between the research required for approval and the need for information to assist clinicians in the everyday use of products. Selection Criteria FDA's needs relate to the necessity for going beyond the current voluntary reporting system to obtain needed safety and effectiveness information for providing guidance to practitioners on appropriate product use. The current post-marketing surveillance system provides only a fraction of the actual number of problems associated with product use, with only limited information available on the numbers of patients exposed to products.
Little information is available on the interaction between the provider, product and patient.
This is particularly important when a high degree of skill is required of either the provider or patient to use a product, thus making it difficult to determine whether problems relate to provider or patient error, product defect or an adverse event. Submission Process Nominations of topics and suggestions for organization of the Centers should focus on broad aspects of the legislative program as set out above.