During an April 23rd FDA hearing to gather input on ways to modernize the clinical research process, The Association of Clinical Research Organizations (ACRO) provided FDA a number of suggestions to improve the drug development process. ACRO’s main suggestion was to appoint a Chief Innovation Officer within the FDA. ACRO also recommended the following: incorporating modern regulatory science into clinical trial design, simplifying the informed consent process, and expanding regulatory cooperation and information sharing. ACRO’s Executive Director, Doug Peddicord, Ph.D was present and provided comments shared that he thought the hearing felt disorganized. at a public hearing titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.” To learn more, click here to read an article in PharmaPro, and to read ACRO’s statement, click here (insert http://www.fiercecro.com/press-releases/acro-testifies-fda-clinical-trial-modernization ). It’s not to late to provide your comments. We encourage you to submit your input to the FDA by the deadline of May 31st.
Written and electronic comments accepted until May 31, 2012. Submit to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.