United States of America. The Food and Drug Administration has announced the availability of a draft guidance for industry entitled “Qualifying for Pediatric Exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act”. The FDA is also requesting the submission of proposed paediatric study requests. This guidance is intended to assist industry in interpreting newly enacted provisions of the Food and Drug Administration Modernization Act of 1997 which permit certain applications to obtain an additional 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits information relating to the use of the drug in the paediatric population. The guidance with be updated as appropriate and will remain in effect until superseded by regulations or a new guidance.
Copies of the draft guidance are available from the Drug Information Branch, (HFM- 210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA (with one self- addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.
Reference(s): Federal Register 63(129): 37402-3 (1998).