The FDA’s Pharmaceutical Science & Clinical Pharmacology Advisory Committee is an influential part of the FDA as it provides recommendations.
The FDA’s Pharmaceutical Science & Clinical Pharmacology Advisory Committee is an influential part of the FDA as it provides recommendations to the Commissioner of Food and Drugs involving scientific and technical issues regarding the safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases. Additionally, the Pharmaceutical Science & Clinical Pharmacology Advisory Committee provides advice on the quality characteristics which drugs are purported to have, and as required, any other product for which the Food and Drug Administration has regulatory responsibility. This 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.
There are 14 voting member positions including two chairpersons. These members and chairpersons who are knowledgeable in a variety of fields which include 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, related biomedical and pharmacological specialties, current good manufacturing practices, and quality systems implementation.
The Pharmaceutical Science & Clinical Pharmacology Advisory Committee has not had any meetings during 2014 thus far. However, there were three scheduled for 2013; two of which were cancelled.
A meeting on September 25th of 2013 was held to discuss the optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. During this meeting, the FDA sought input on: (1) best practices in DDI communication through prescription drug product labels (i.e., “package inserts”), namely: a) appropriate format for presentation (e.g. tables, graphs, text) of DDI information; b) level of detail of DDI study results; and c) appropriate wording for clinical recommendations based on empirical data vs. anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users (e.g., prescribers, dispensers, DDI database curators) in decision making and/or communication. During this meeting, there were four discussion questions and no voting questions.
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