Participants will learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements, and also create awareness of current activities.

• Drug Development & Approval Process https://www.fda.gov/drugs/development-approval-process-drugs
• CDRH Learn https://www.fda.gov/training-and-continuing-education/cdrh-learn
• CBER OTAT Learn: https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn

• Identify and solve drug/device regulatory issues as they arise within the activity content.
• State the appropriate department and FDA point of contact for medical product submissions.
• Identify and apply several essential components of New Drug Applications (NDAs), Biologics License Applications (BLAs), Medical Device submissions.

Physicians, pharmacists, nurses, 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.

• Alimchandani, Meghna, MD, Physician, OBE/CBER - nothing to disclose
• Anderson, Nelson, Policy Analyst, FDA/CDRH/OPEQ - nothing to disclose
• Bediakoh, Ruth, CSO, CDRH - nothing to disclose
• Bernhardt, Jessica, MS, ESG Program Manager, FDA - nothing to disclose
• Brookbank, Jason, Assistant Division Director, CDRH/OM/DFM - nothing to disclose
• Burk, Laurel, PhD, Supervisory Biomedical Engineer, Center for Devices and Radiological Health - nothing to disclose
• Califf, Robert M., MD, Commissioner, Food and Drug Administration - I have the following relationship(s): Various - My financial disclosure report and ethics agreement are publicly available documents (https://www.oge.gov/web/oge.nsf/home).
• Cavazzoni, Patrizia, MD, Director, Center for Drug Evaluation and Research, FDA - nothing to disclose
• Chang, William, MBA, PE, Medical Device Specialist, ORA/OMDRHO - nothing to disclose
• Chin, Doris, R. Ph, Consumer Safety Officer, FDA - nothing to disclose
• Colburn, Scott, RN, BSN, MS, Director, Standards and Conformity Assessment Program (S-CAP), CDRH - nothing to disclose
• Conway, Gregory, PhD, MA, Biological Reviewer, U.S. Food and Drug Administration - I have the following relationship(s): American Type Culture Collection - Employee
• Crandall, Heather, Operations Research Analyst, FDA - nothing to disclose
• Downey, Christopher, PhD, Director, Division of Biotechnology Manufacturing, FDA/CDER/OPMA - nothing to disclose
• Elenburg, Shelby, MD, Physician, Food and Drug Administration - nothing to disclose
• Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
• Goode, Jennifer, BS BME, Biocompatibility Program Advisor, FDA CDRH Office of Product Evaluation and Quality - nothing to disclose
• Gossmann, Alexej, PhD, Staff Fellow, FDA/CDRH/OSEL/DIDSR - nothing to disclose
• Holter, Kendra, RN, MSN, Consumer Safety Officer, CDRH - DICE - nothing to disclose
• Hornatko-Munoz, Adrienne, RAC (US), Senior Advisor for Pediatric Regulatory Review, FDA/CBER - nothing to disclose
• Klinker, Matthew, PhD, Biologist, US Food & Drug Administration - nothing to disclose
• Kunkoski, Elizabeth, MS, Health Science Policy Analyst, CDER - nothing to disclose
• Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
• Lapteva, Larissa, MD, Associate Director, CBER - nothing to disclose
• Lee, Kerry Jo, MD, Associate Director for Rare Diseases, FDA - nothing to disclose
• Mallis, Elias, Director, Division of Industry and Consumer Education, U.S. Food and Drug Administration - nothing to disclose
• Marks, Peter, MD, PhD, Center Director, FDA/CBER - nothing to disclose
• Maxfield, Kimberly, PhD, Lead for BsUFA III Reg Sci Program, Food and Drug Administration - nothing to disclose
• Miller, Mara, MA, Division Director, OTP/ORMRR - nothing to disclose
• Montes, Yvette, Consumer Safety Officer, Center for Devices and Radiological Health - nothing to disclose
• Moreira, Ernesto, MD, Pharmacology/Toxicology Reviewer, FDA - nothing to disclose
• Patel, Paresma, PhD, Division Director, Food and Drug Administration - nothing to disclose
• Phillips, J. Paul, MS, Director, OPO, FDA/CDER/OND - nothing to disclose
• Potter, Andrew, PhD, Mathematical Statistician, FDA/CDER/OTS/OB/DBI - nothing to disclose
• Resnick, Jonathan, PMP, Business Informatics Specialist, FDA, CDER, OBI - nothing to disclose
• Ricci, M. Stacey, D.Sc, Director, Scientific Review Staff, FDA/CDER/OND/OTBB - nothing to disclose
• Schnupp, Lashawn, PharmD, Regulatory Health Project Manager, FDA - nothing to disclose
• Scott, John, PhD, Director, Division of Biostatistics, CBER/OBPV - nothing to disclose
• Seeto, Wen, PhD, Staff Fellow, FDA - nothing to disclose
• Shuren, Jeffrey, MD, JD, Director, CDRH, FDA - nothing to disclose
• Slack, Mary Ann, BS, Director, Office of Strategic Programs, CDER - nothing to disclose
• Smith, Derek, PhD, Deputy Director, CDER/OPQ/OPMA - nothing to disclose
• Smith, Kimberly, MD, MS, Medical Officer, FDA/CDER - nothing to disclose
• Sprau, Andrew, MS, Consumer Safety Officer, Food and Drug Administration - nothing to disclose
• Sterrett, Lolita, PharmD, pharmacist, fda - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
• Tartal, Joseph, Division Deputy Director, Division of Industry and Consumer Education - nothing to disclose
• Thompson, Elizabeth, MS, Chief Project Management Staff, FDA/CDER/OND/ORO/DRONPD - nothing to disclose
• Vatsan, Ramjay, Associate Director for Policy, FDA - nothing to disclose
• Wang, Ray, MBA, MS, Director, Data Standards Staff, CDER - nothing to disclose
• Wang, Wei, PhD, Microbiologist, FDA/CBER/OCBQ/DMPQ - nothing to disclose
• Weil, Kathy, BSN, MS, Senior Science Policy Analyst, FDA/CDER/OND/IO/SPiRIT - nothing to disclose
• Welch, Joel, PhD, Associate Director for Science & Biosimilar Strategy, Office of Biotechnology Products/Office of Pharmaceutical Quality/CDER - nothing to disclose
• Wilbon, Tonya, B.S., Branch Chief, FDA/CDRH/OCE/DICE - nothing to disclose
• Xu, Lei, MD, PhD, Medical Officer, FDA - nothing to disclose

• Lapteva, Larissa, MD, Associate Director, CBER - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

• Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose