Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture Description
This webinar will provide health care providers with information and knowledge on how to answer questions that patients may have about narrow therapeutic index (NTI) generic drugs, such as how the FDA recognizes the importance of bioequivalence in NTI generic drugs and has stricter standards for bioequivalence of NTI drugs than for other generic drugs. The presentation will also give providers information on FDA's post-market research efforts to ensure therapeutic equivalence of generic NTI drugs.

References

• LX Yu, W Jiang, X Zhang, R Lionberger, F Makhlouf, DJ Schuirmann, L Muldowney, M-L Chen, B Davit, D Conner and J Woodcock. Novel Bioequivalence Approach for Narrow Therapeutic Index Drugs. Clinical Pharmacology & Therapeutics 2015.
• W Jiang and LX Yu. Bioequivalence for narrow therapeutic index drugs. In L.X. Yu and B.V. Li (eds.), FDA Bioequivalence Standards, 2014 AAPS Advances in the Pharmaceutical Sciences Series, Springer Science New York 2014.
• W. Jiang. Bioequivalence Approach for Narrow Therapeutic Index (NTI) Drugs. Antiepileptic drug and device trials XIII, May 13-15, 2015.
• Wenlei Jiang. Pharmaceutical Quality of NTI Drug Products. 2011 Advisory Committee for Pharmaceutical Sciences and Clinical Pharmacology, Jul 26, 2011.

Series Objectives

• Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
  
  
• Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.

Learning Objectives After completion of this activity, the participant will be able to:

• Recognize general characteristics of NTI drugs
• Describe FDA’s approach and criteria to evaluate the bioequivalence of generic NTI drugs
• Discuss examples of FDA’s approved generic NTI drugs demonstrating therapeutic equivalence to brand counterparts in patient populations
• List opportunities to facilitate global generic NTI drug development and increase generic NTI substitution

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.

Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Jiang, Wenlei, PhD, Senior Advisor for Innovation and Strategic Outreach, Office of Research and Standards/Office of Generic Drugs/CDER - nothing to disclose

Planning Committee

• Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
• De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
• Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
• Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

• Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.