'Combination products' presentation slideshows

The Future of Combination Products

The Future of Combination Products. Bradley Merrill Thompson, MBA, JD, RAC Epstein Becker & Green PC RAPS San Francisco, CA April 27, 2007. Topics. Overview Where are Combination Products Going? Where is Combination Product Regulation Going?

1.32k views • 58 slides

Herbs Every Pediatrician Should Know

Herbs Every Pediatrician Should Know. Kathi J Kemper, MD, MPH Director, Center for Integrative Medicine Professor of Pediatrics and Public Health Sciences Wake Forest University Health Sciences . Disclaimer.

708 views • 50 slides

Medical textiles, Leeds: Things that really matter

Medical textiles, Leeds: Things that really matter. Dr. Parikshit Goswami Centre for Technical Textiles, University of Leeds, UK Lecturer in Textile Technology p.goswami@leeds.ac.uk. NIFT Kolkata. About me. Lecturer in Textile Technology MSc Medical Textiles Programme Leader

554 views • 39 slides

Changing Smoking Habits

Changing Smoking Habits. Politics of Tobacco Regulation. FDA v. Brown & Williamson Tobacco Corp ., 529 U.S. 120 (U.S. 2000). Pharmacology of Tobacco. Primary drug effect is nicotine Strong nervous system drug using in classic neurophysiology research Great natural bug killer

490 views • 36 slides

Critical Path Public Docket: Overview for the FDA Science Board

Critical Path Public Docket: Overview for the FDA Science Board. November 5, 2004. Presentation Overview. Themes Caveats and Cautions Biggest Concerns Other Priority Hurdles Other Messages For More Information. Overwhelming Support.

471 views • 35 slides

New Highlights in Central Line- Associated Bloodstream Infection and Surgical-Site Infection Prevention

New Highlights in Central Line- Associated Bloodstream Infection and Surgical-Site Infection Prevention. Rabih O. Darouiche, MD VA Distinguished Service Professor Director, Center of Prostheses Infection at Baylor College of Medicine Safe Practices Webinar February 18, 2010.

979 views • 33 slides

AdvaMed Combination Products Seminar Case Studies and Practical Challenges Cross-Labeled Products May 29, 2008

AdvaMed Combination Products Seminar Case Studies and Practical Challenges Cross-Labeled Products May 29, 2008. Winifred C. Wu V.P. Regulatory Affairs Medtronic Neuromodulation Diana Salditt Distinguished Regulatory Affairs Advisor Medtronic Corporate Regulatory Affairs. Outline .

472 views • 33 slides

Fostering Innovation on the Critical Path to Medical Device Development

Fostering Innovation on the Critical Path to Medical Device Development. BME-IDEA Workshop, September 28, 2005. Donna-Bea Tillman, Ph.D Director, Office of Device Evaluation Center for Devices and Radiological Health. FDA Mission: Historical Basis. Protect the public from unsafe products.

631 views • 31 slides

Arrowhead Drug Delivery Summit San Francisco May 14, 2009

Drug Delivery -- Perspectives on the FDA Regulatory Environment. Arrowhead Drug Delivery Summit San Francisco May 14, 2009. Michael A. Swit, Esq. Vice President. Standard Disclaimers. Views expressed here are solely mine and do not reflect those of my firm or any of its clients.

438 views • 30 slides

Enhancing the Safety and Efficacy of Pharmaceuticals

Enhanced Pharmaceuticals, Inc. Enhancing the Safety and Efficacy of Pharmaceuticals. SAFE HARBOR STATEMENT.

732 views • 27 slides

Biotechnology Chemical Pharmaceutical Customer Partnership

321 views • 22 slides

Biotechnology Chemical Pharmaceutical Customer Partnership

392 views • 22 slides

Division of Cellular and Gene Therapies (DCGT) Overview of Activities

Division of Cellular and Gene Therapies (DCGT) Overview of Activities. Raj K. Puri, M.D., Ph.D. Division Director, Division of Cellular and Gene Therapies FDA, Center for Biologics Evaluation and Research. Outline. Mission and organizational structure Regulatory scope Approach to research

462 views • 20 slides

Efficacy and Safety Profiles of New and Emerging Menopause Treatments

Efficacy and Safety Profiles of New and Emerging Menopause Treatments. Kathryn A. Martin, MD Reproductive Endocrine Unit Massachusetts General Hospital Boston, Massachusetts. Hormone Products. Estrogen Low doses Alternate routes of administration Progestins Micronized progesterone

467 views • 20 slides

Politics of Tobacco Regulation

Politics of Tobacco Regulation. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S. 2000). Pharmacology of Tobacco. Primary drug effect is nicotine Strong nervous system drug using in classic neurophysiology research Great natural bug killer An oily plant that makes a smoky fire

439 views • 19 slides

Combination Products CBER Report

Combination Products CBER Report. MDUFAMA Educational Seminar November 2002. Designation of Regulation of Combination Products. Achievements 1. Establish Office of Combination Products within 60 days 2. Prompt assignment of lead center 3. Timely and effective premarket review

328 views • 15 slides

Judy Manning, PhD Office of Population and Reproductive Health Bureau for Global Health

277 views • 13 slides

Consumer Care

Consumer Care. Bayer Corporation Consumer Care Division September 19, 2002 Allen H. Heller, MD Vice President, Global Research & Development. Bayer OTC Analgesic Products. Acetaminophen Containing - Multi-symptom Combinations Alka-Seltzer ? Plus -- Cough/Cold/Allergy Midol ? -- Menstrual

191 views • 9 slides

Webinar On FDA Approval Process for Combination Products

This 2 hours webinar will provide a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

213 views • 2 slides

Reference Links

Reference Links. FDA General - www.fda.gov/oc/history/default.htm Drug law history- www.druglibrary.org/schaffer Devices- www.fda.gov/cdrh/devadvice CLIA- www.fda.gov/cdrh/clia/ Drugs-NDA www.fda.gov/cder/regulatory/applications/ USER FEES- www.fda.gov/oc/oms/ofm/userfees/

224 views • 1 slides