美国FDA 指导原则 如何遵守《儿科研究公平法》 英文原版.pdfVIP

Guidance for Industry How to Comply with the Pediatric Research Equity Act DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions on the content of the draft document contact Grace Carmouze, 301-594-7337 or Leonard Wilson, 301-827-0373. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) September 2005 Procedural Guidance for Industry How to Comply with the Pediatric Research Equity Act Additional copies are available from: Office of Training and Communications Division of Drug Information, HFD-240 Center for Drug Evaluation and Research (CDER) Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 (Internet) /cder/guidance/index.htm or Office of Communication, Training, and Manufacturers Assistance (HFM-40) Center for Biol