FDA regulations for growth factors and related products.

Abstract

Biological products, including the majority of growth factors, are regulated by the Center for Biologics Evaluation and Research (CBER) in the U.S. Food and Drug Administration (U.S.FDA) under two statutes; U.S. Federal Food Drug and Cosmetics (FDC) act and the U.S. Public Health Service act. As stipulated in the U.S. Code of Federal Regulations (21 CFR) under the FDC act, the testing of new products in humans is conducted under an Investigational New Drug (IND) application. The primary objective of the FDA in all Phases of an investigation is assure safety of human subjects. During phase II and phase III studies, additional assurance regarding the scientific quality of the clinical investigation is required. A marketing approval is granted by CBER following the review of Product License Applications (PLA) and Establishment License Applications (ELA). CBER's review process provides guidance to the manufacturers of biological products towards the development of safe and effective biological products for human use. Information pertinent to preclinical issues and clinical trial design is presented here with a special emphasis on the non-hematopoietic growth factors.