This live web event has ended. Thank you for attending.
About this FREE webinar
The U.S. Food and Drug Administration approved labels for all drug and biologic products include extensive information on patient populations, disease indications and potential drug and food interactions for those products. These labels guide the clinical use of approved products and are familiar to and are well-used sources of information for both practitioners and researchers. Many are less familiar with how to access and use additional drug review information available from FDA.
The FDA Office of Clinical Pharmacology maintains publicly available, minimally redacted review documents containing significant information about the clinical and pre-clinical studies used to support approval of new drugs. Study information typically includes details about dosing, drug-drug interactions and population-specific findings that inform the labeled indications and contraindications. FDA review documents can be a valuable resource to assist in clinical decision making, especially in cases at the limits of the approved indications. Review information can also be used as inputs for population-based or physiologic-based modeling for drug development.
The FDA is interested in encouraging the use of these documents in both clinical and research settings and in promoting potential collaborations with researchers to advance the use of real-world evidence and FDA resources in drug development.
- Locate and navigate through FDA review and industry documents to find information relevant to specific clinical or research use cases.
- Describe how FDA review and industry documents can be used to resolve clinical questions related to dosing or drug-drug interactions.
- Explain the use of information from FDA review and industry documents to advance a research question related to drug development.
The webinar, “Navigating and Understanding FDA Review Documents,” is a knowledge-based, continuing education activity (UAN: 0581-9999-19-160-L04-P) co-sponsored by AAPS and AACP. The live activity is approved for 1.50 contact hours (0.150 CEUs). To obtain CPE credit, pharmacists must attend the live webinar on October 24, and complete a post-assessment and evaluation via the AACP CE management system, Learning Express CE. A passing score of 75% or higher is required to obtain credit. CPE credit information will be electronically transmitted to CPE Monitor. Pharmacists should login to their NABP e-Profile account to obtain a valid statement of credit if needed. The deadline to complete the post-assessment and evaluation in order to obtain CPE credit is Monday, December 23, 2019.