PPT-Post-Approval Drug Issues

FDLIIntroduction to Drug Law Regulation By Marc J Scheineson Esq Alston amp Bird 950 F Street NW Washington DC 20004 202 2393465 marcscheinesonalstoncom November 7 2013. 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.. 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 . . . .. NEED FOR FURTHER RESEARCH. PATRICIA M KHU, MD,MS. UNIVERSITY OF THE PHILIPPINES MANILA . RESEARCH ETHICS BOARD (UPMREB). CARDINAL SANTOS MEDICAL CENTER . RESEARCH ETHICS REVIEW COMMITTEE (CSMC-RERC). 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. NEED FOR FURTHER RESEARCH. PATRICIA M KHU, MD,MS. UNIVERSITY OF THE PHILIPPINES MANILA . RESEARCH ETHICS BOARD (UPMREB). CARDINAL SANTOS MEDICAL CENTER . RESEARCH ETHICS REVIEW COMMITTEE (CSMC-RERC). 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. 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.. 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. John Paul Joson MSN CNS. 1. Objectives. Role of the F.D.A.. Phases of Approval. Controlled Substances, Drug Schedules, and Teratogenic Risks. 2. F.D.A.. U.S. Food and Drug Administration. 1997 Black Box Warnings. 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 . 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. PY 19 WIOA Funding. Funding was ~ about the same; tad in our favor.. 2.4 times more volume in other regions . . CCWI has 2.2 times more volume. . NWDB has 2.6 times more volume.. PY 19 Volume Persons Served.