PPT-Drug Approval and Regulation

John Paul Joson MSN CNS 1 Objectives Role of the FDA Phases of Approval Controlled Substances Drug Schedules and Teratogenic Risks 2 FDA US Food and Drug Administration 1997 Black Box Warnings. 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.. development . Dr. S. Padmaja, Managing Partner, iProPAT. August 24, 2012. ©. What is Generic ?. Same active ingredient(s).. Same route of administration.. Same dosage form.. Same strength.. Same conditions of use.. HSPM J712. 11/10/2010. What is the real product of the drug industry?. Drugs?. New drugs?. Prices of brand name drugs >> marginal cost of production. Industry argues that the prices of new drugs reflect the cost of research and development. Patent Linkage in the USA. Lawrence T. Welch. Eli Lilly and Company. Hatch-Waxman Act – Submission of Patent Information. . Applicant shall file with the application the patent number and the expiration date of any patent which claims the drug . . . or which claims a method of using the drug and with respect to which a claim of patent infringement could reasonably be asserted . . . .. 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. Additionally: . Introduction of “Approval Numbering” and “Approval Marking” applied to the new draft LSD, RID and RRD Device Regulations . Page . 1. GRE Informal Working Group „. Simplification. 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.. Marlene E. Haffner, MD, MPH. CEO, Haffner Associates, LLC. Orphan Drugs Summit 2012. Thursday, 27. th. September 2012. Current . Pharma. Trends. Slow . pharma. industry growth. Patent expiration. Chapter 1. John Paul Joson MSN CNS. OBJECTIVES. What is it?. History. Classification of Therapeutic Agents as :. Drugs. Biologics. Complementary and Alternative therapies. Therapeutic and Pharmacologic Class. Investigational New Drug Application (IND); Summary of regulations and guidelines . Introduction of . cGMP's. /principles of validation . Introduction to QA/QC principles . Good Laboratory Practice (GLP) compliance . FDLI-Introduction to Drug Law Regulation. By: . Marc J. Scheineson, Esq.. Alston & Bird. 950 F Street, N.W.. Washington, D.C. 20004. (202) 239-3465. marc.scheineson@alston.com. November 7, 2013. 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. 2019/9/3-5. SLR32 in TOKYO. This Revision 1 (added new slides 6 and 7) reflects the latest status of discussion . in Brussels at SLR-34 (. 4-6 November 2019). SLR-35-21 . Based. on SLR-32-19/Rev.1. Submitted. the effect of GRPE/2017/02. (UN R83.07 Supplement 6). Informal document . GRPE-79-10. 79. th. GRPE, 21-24 May 2019. Agenda item 3.(a). Submitted by the experts of OICA. 2. Background (1):. Before Supplement 6, paragraph 1.1. of .