This course is designed to provide participants with a strong, basic foundation in understanding the FDA's drug, biologic and medical device regulatory requirements. Presentations include Q&A sessions with subject matter experts from CDER, CDRH, and CBER.

• 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

• Problem solve and address drug/device regulatory issues as they arise based on activity content.
  
• Identify the appropriate FDA office to contact relevant to their medical product submission.
  
• Identify and apply several essential components of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submission.
  

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.

• ALBERT, JENNIFER, RN, BSN, Regulatory Project Manager, FDA/CBER/OTAT - nothing to disclose
• Allen, Ekaterina, Lead Consumer Safety Officer (Acting), FDA/CBER/OCBQ/DMPQ/MRB2 - nothing to disclose
• Andress, Meredith, MPH, Recall Coordinator, FDA-ORA - nothing to disclose
• BROOKS, DANIELLE, PhD, Biologist, U.S. Food and Drug Administration - nothing to disclose
• Behr, Virginia, BS, Ombudsman, FDA/CDER/Office of Executive Programs - nothing to disclose
• Brubaker, Scott, Director, FDA/CBER/OTAT/DHT - nothing to disclose
• Bryan, Wilson - nothing to disclose
• Bugin, Kevin, PhD, RAC, Deputy Super Office Director of Operations, US FDA - nothing to disclose
• Cavazzoni, Patrizia, MD, Director, Center for Drug Evaluation and Research, FDA - nothing to disclose
• Concato, John, MD, Supervisory Physician, CDER-OMP - nothing to disclose
• Das, Asha, MD, Physician, OTAT - nothing to disclose
• Di Prima, Matthew A., PhD, Materials Scientist, US Food and Drug Administration - nothing to disclose
• Donat, Adam, Deputy Director, Division of Clinical Science and Quality - nothing to disclose
• Dyer, Jake, P.E., PMP, Regulatory Officer, CDRH - nothing to disclose
• Finn, Tom, PhD, CMC reviewer, FDA - nothing to disclose
• Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
• Gilbert, Susannah, MS, Policy Analyst, CDRH - nothing to disclose
• Golding, Basil, supervisory medical officer, HHS, FDA, CBER, OTAT, DPPT - nothing to disclose
• Gopal, Vidya, CSO, FDA/CDRH - nothing to disclose
• Gormley, Andrea, PharmD, JD, Pharmacist, FDA - nothing to disclose
• Gray, Andrea, FDA - nothing to disclose
• Hall, Melissa, Consumer Safety Officer, FDA - nothing to disclose
• Hart, Elizabeth, MD, Branch Chief, General Medicine 1, OTAT, CBER, FDA - nothing to disclose
• Ibrahim, John, PharmD, BCPS, Associate Director for Regulatory Affairs, FDA - nothing to disclose
• JACQUELINE, WARE, PharmD, Deputy Director, FDA/CDER/OND/ORO - nothing to disclose
• Karandish, Safa, BS, MT, Consumer Safety Officer, Food and Drug Administration - nothing to disclose
• Kennedy, Niloofar, MS, Regulatory Project Manager, OTAT - nothing to disclose
• Kolejian, Sevan, PharmD, MBA, BCPPS, SE/ pharmacist, FDA I received Salary from PRN Pharmacist at Johns Hopkins Hospital for a role as Other - PRN Pharmacist at Johns Hopkins Hospital.
• Kraus, Stefanie, JD, MPH, Senior Regulatory Counsel, FDA - nothing to disclose
• Kwilas, Anna, PhD, Lead Biologist, Food and Drug Administration - nothing to disclose
• Lapteva, Larissa, MD, Associate Director, CBER - nothing to disclose
• Lauritsen, Kristina, PhD, Combination Product Policy Advisor, Center for Drug Evaluation and Research - nothing to disclose
• Liu, Qi, PhD, Associate Director for Innovation & Partnership, Office of Clinical Pharmacology | Office of Translational Sciences | Center for Drug Evaluation and I received Stocks from I opened an account on Robinhood on 2/13/2021. The Robinhood app gave me a free share of random stock when I opened the account, and it turned out to be one share of Unity Biotechnology (UBX) with a total worthy of about $8. I tried to sell it immediately but was not able to do so because the App required that I had to hold it for at least 3 trading days before I could sell it. On 2/19, I was notified by the App that the UBX share "has settled and can now be traded". I immediately sold it for $7.79. Now I no longer have any share of UBX. for a role as Other.
• Lyndaker, Alison, Operations Research Analyst, Food and Drug Administration - nothing to disclose
• Mallis, Elias, Director, Division of Industry and Consumer Education, U.S. Food and Drug Administration - nothing to disclose
• Maramkhah, Fariba, Master degree, Consumer Safety Officer, FDA - nothing to disclose
• Margerrison, Edward, PhD, Director, Office of Science and Engineering, CDRH - nothing to disclose
• Marks, Peter, MD, PhD, Center Director, FDA/CBER - nothing to disclose
• Moos, Malcolm, M.D., Ph.D., medical officer, FDA - nothing to disclose
• Muldowney, Laurie, Deputy Director, FDA/CDER/OC/OSI - nothing to disclose
• Nell, Diane, PhD, Consumer Safety Officer, CDRH/OCE/DICE - nothing to disclose
• Ngan, Kelly, PharmD, MPH, Chief Project Management Staff, Food and Drug Administration - nothing to disclose
• Pamidimukkala, Geeta, Deputy Division Director, ORP/Div1, FDA - nothing to disclose
• Price, Graeme, PhD, Research Microbiologist, FDA CBER OTAT DCGT - nothing to disclose
• Purohit-Sheth, Tejashri, Director, DCEPT, CBER/OTAT - nothing to disclose
• Resnick, Jonathan, PMP, Business Informatics Specialist, FDA, CDER, OBI - nothing to disclose
• Senay, Seyoum, MS, Supervisory Operations Research, FDA - nothing to disclose
• Shuren, Jeffrey, MD, JD, Director, CDRH, FDA - nothing to disclose May reference off-label use.
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
• Tartal, Joseph, Division Deputy Director, Division of Industry and Consumer Education My spouse received Other - hourly wage from New Horizons Diagnostics Corporation for a role as Other - contractor, manufacturer. My spouse received Other - hourly wage from New Horizons Diagnostics Corporation for a role as Other - contractor.
• Urban, Daniel, PhD, Biologist, PTB1 / DCEPT / OTAT / CBER / FDA - nothing to disclose
• Wilbon, Tonya, B.S., Branch Chief, FDA/CDRH/OCE/DICE - nothing to disclose
• Wilson, Wendy, PhD, Division Director, CDER/OPQ/ONDP/DNDPII - nothing to disclose
• Woodcock, Janet, MD, Acting Commissioner of Food and Drugs, FDA - nothing to disclose
• Wyllie, James-Denton, Director, Food and Drug Administration - nothing to disclose
• Xu, Lei, MD, PhD, Medical Officer, FDA - nothing to disclose

• Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
• Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

• Harrison, Catherine, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose