Navigating and Understanding FDA Review Documents

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Description

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.

Learning Objectives

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.

Who will benefit from attending this learning event? Clinical pharmacists, pharmacy faculty, and researchers who use FDA data in their research

Accredited by

“The American Association of Colleges of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.”
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.

Contributors

Kunyi Wu, Pharm.D.

Kunyi Wu, PharmD is a Clinical Pharmacologist in the Office of Clinical Pharmacology at CDER, FDA. Dr. Wu has worked at FDA for five years as a clinical pharmacology reviewer for anti-infective, transplant, ophthalmology products, and submissions under the Animal Rule. Dr. Wu received her Doctor of Pharmacy degree from The Ohio State University and completed her Clinical Pharmacology fellowship training at FDA.
J. Russell May, Pharm.D., FASHP

J. Russell May, Pharm.D., FASHP is a Clinical Professor and Associate Department Head in the Department of Clinical and Administrative Pharmacy at the University of Georgia College of Pharmacy. Prior to his move to academia full time in 2003, Dr. May was a drug information specialist and clinical manager in the Pharmacy Department at the Medical College of Georgia (MCG) Health System for 22 years, including serving as Director of Pharmacy from 1998 – 2003. Since graduating from the University of Kentucky Pharm.D. and Hospital Residency Programs in 1981, Dr. May has focused his practice in the areas of drug information and drug policy development. He currently serves on the Residency Advisory Council for the PGY-1 and three PGY-2 (critical care, oncology, and pediatrics) programs at Augusta University Health System (co-sponsored by the University of Georgia). In 2007, he was named Teacher of the Year at the University of Georgia College of Pharmacy. He is a Fellow of the American Society of Health-System Pharmacists and has served on the ASHP Executive Committee of the Section of Clinical Specialists and the ASHP Commission on Credentialing. He is a past president of the Georgia Society of Health System Pharmacists. Dr. May has served as a visiting professor at Misr International University in Cairo Egypt and assisted with the development of their Drug Information Center, the first in Egypt. Dr. May was the recipient of the 2014 Distinguished Drug Information Practitioner Award from the American College of Clinical Pharmacy Drug Information Practice and Research Network. Dr. May received the 2018 Paul F. Parker Award from the University of Kentucky.
Brian Furmanski, Ph.D.

Dr. Furmanski has over 10 years of experience in the development of small molecule, oligonucleotide, radiopharmaceutical, and biologic therapeutics from an industrial and regulatory perspective. He has provided expert guidance on the design and interpretation of human clinical pharmacology, toxicokinetic, drug metabolism, bioanalytical and biopharmaceutical quality findings through the examination of pharmacokinetic and pharmacodynamic analyses across multiple therapeutic areas.

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Description

Contributors

Kunyi Wu, Pharm.D.

J. Russell May, Pharm.D., FASHP

Brian Furmanski, Ph.D.