PPT-Regulatory Issues Introduction to the Regulatory Approval Process; Overview of the FDA

Investigational New Drug Application IND Summary of regulations and guidelines Introduction of cGMPs principles of validation Introduction to QAQC principles Good Laboratory Practice GLP compliance . Vivek Y. Reddy MD. 1. *, Douglas N. Gibson MD. 2. , . Saibal. Kar. 3. , William O’Neill MD. 4. , . Shephal. K. . Doshi. MD. 5. , Rodney P. Horton MD. 6. , Maurice . Buchbinder. MD. 7. , Nicole T. Gordon BSEE. Improving the Quality, Quickness. and Quantity of Access to Alzheimer’s. Disease Treatments. By Whitney Davis. 2011 WISE Intern. University of Arkansas. August 4, 2011. US Food and Drug Administration. Technical Assistance. If . you encounter problems during this training session, call WebEx Technical Support at 1-866-229-3239 and provide the session ID.. If you are unable to join the audio conference, call Global Crossing Ready-Access audio conferencing at 1-800-788-6092.. Vivek Y. Reddy MD. 1. *, Douglas N. Gibson MD. 2. , . Saibal. Kar. 3. , William O’Neill MD. 4. , . Shephal. K. . Doshi. MD. 5. , Rodney P. Horton MD. 6. , Maurice . Buchbinder. MD. 7. , Nicole T. Gordon BSEE. Aquaculture Drug Workshop. Bozeman, Montana. July 31, 2013. Meg Oeller, DVM . FDA Center for Veterinary Medicine. 1. Caveat. Please note that these slides have been altered slightly from those used in the presentation at the aquaculture workshop. This was done largely to facilitate making these slides 508 compliant for posting on our website. The pertinent content has not been changed.. 12. th. Annual Career Strategies Conference. Life Sciences Life Cycle:. Women of Color. September 21, 2016. | . 2. Panelists. Adrienne Gonzales. Bristol-Myers Squibb. Shirell Gross. Bayer. Cara . Edwards. FDA Modeling and Simulation Working Group. Sponsored by the Office of the Chief . Scientist Fall 2016. Main . Objectives. :. Raise awareness of the successes, challenges and opportunities for modeling and simulation to advance regulatory science at the FDA;. MSACL. April 4, 2019. Majda Haznadar, Kris Roth, Doug Jeffery. majda.haznadar@fda.hhs.gov. kristian.roth@fda.hhs.gov. doug.jeffery@fda.hhs.gov. www.fda.gov. www.fda.gov. DISCLAIMER. This presentation is intended for informational purposes only and does not constitute legal or regulatory advice. Please see the Federal Food, Drug, and Cosmetic Act and 21 CFR Subchapter H for a full list of requirements by FDA. to request assistance Our Office of Information Management and Technology OIMT will work with your firm to set up secure communicationsPlease notify the investigator of any delays due to this encrypti trengthening the Accelerated Approval Pathway1STRENGTHENING THE ACCELERATED APPROVAL PATHWAYAN ANALYSIS OF POTENTIAL POLICY REFORMS AND THEIR IMPACT ON UNCERTAINTYACCESS INNOVATION AND COSTSApril26 20 New Devices. Roxana Mehran, MD, MSCAI, FACC, FAHA, FESC. Mount Sinai Professor Of Cardiovascular Clinical Research and Outcomes. Professor of Medicine (Cardiology), and Population Health Science and Policy. Balancing Gold Standard Evidence with Patient-Centered Flexibility. Sarah L. Wicks, JD, MPH. University of Minnesota – Rare Disease Day 2020. February 28, 2020. 1. Overview. FDA’s “Gold Standard” for Approval. patent brand-name medicines. Low-cost generic drugs—Food and Drug Administration (FDA)-approved, interchangeable versions of the same products made by different manufacturers—were considered Emergency use is different than. Expanded Access ("compassionate use"). Expanded Access. Serious disease, no other satisfactory alternative (may be urgent but not emergent). Research*. Requires IRB approval (or IRB chair concurrence).