Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Purpose

The Committee shall provide advice on scientific and technical issues concerning the safety, and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases, and as required, the quality characteristics which such drugs purport or are represented to have, and as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. The Committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA’s drug regulatory responsibilities and its critical path initiatives related to improving the efficacy and safety of drugs and improving the efficiency of drug development.

Committee Membership

The Committee shall consist of a core of 26 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pharmaceutical sciences (pharmaceutical manufacturing, bioequivalence research, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, molecular biology, immunology, microbiology) and clinical pharmacology (dose-response, pharmacokinetics-pharmacodynamics, modeling and simulation, pharmacogenomics, clinical trial design, pediatrics and special populations and innovative methods in drug development), biostatistics and related biomedical and pharmacological specialties, current good manufacturing practices, and quality systems implementation. The core of voting members may include two technically qualified members, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include up to four non-voting members who are identified with industry interests.

Contact Information

LCDR Yvette Waples, Acting Designated Federal Officer
Division of Advisory Committee and Consultant Management
Office of Executive Programs
E-mail: ACPS-CP@fda.hhs.gov

FDA Advisory Committee Information Line
1-800-741-8138
(301) 443-0572 (local number)
Please call the Information Line for up-to-date information on meetings.