Mod3_pt1_PharmaIndustry_Lecture_2.pdf;JSESSIONIDVISTA=h8CXTnyGGw25W2TG0phyvjsZCYCKHxsycvCGV9nvccTpsh

Mod3_pt1_PharmaIndustry_Lecture_2.pdf;JSESSIONIDVISTA=h8CXTnyGGw25W2TG0phyvjsZCYCKHxsycvCGV9nvccTpsh

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Unformatted text preview: 8/23/2011 1 Pharmaceutical Industry: A Regulatory Overview Resource: FDAs Center for Drug Evaluation and Research www.FDA.gov/Drugs PHAR 6010 Useful Acronyms 1. CDER Center for Drug Evaluation and Research 2. IND Investigational New Drug 3. NDA New Drug Application 4. CRF Case Report Form 5. OTC drug Over-The-Counter Drug 6. cGMP - Current Good Manufacturing Practices 7. IRB Institutional Review Board 2 8/23/2011 2 Overview 1. Introduction to the Industry 2. FDA Center for Drug Evaluation and Research 3. Pre-Clinical Research 4. IND Review Process & Application 5. Clinical Studies and Phases 6. New Drug Development and Review 3 Introduction to Industry Pharmaceutical Research and Manufacturers of America (PhRMA) PhRMA represents the countrys leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA represents the leading research-based pharmaceutical and biotechnology companies in the United States. 4 8/23/2011 3 Introduction to Industry 10-15 years on average for an experimental drug to travel from the lab to U.S. patients Costs more than $1.318 billion to do research and testing to bring a new medicine to patients Only 5 in 5,000 compounds that enter preclinical testing make it to human testing Only 1 of those 5 is approved for sale 31 new drugs and biologics were approved in 2008 www.PhRMA.org 5 Drug Development Costs $1.318 billion Source: Pharmaceutical Industry Profile 2009; PhRMA. 6 8/23/2011 4 FDA and CDER The Food and Drug Administration through the Center for Drug Evaluation and Research (CDER) monitors and evaluates pharmaceuticals. Its mission: CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs. 7 CDERs Oversight CDER oversees: Prescription, over-the-counter (OTC), and generic drugs Research, development, manufacturing and marketing of drugs Monitors the marketed drugs for previously undetected health risks Monitors truth in advertising for prescription drugs 8 8/23/2011 5 CDERs Jurisdiction Take action to inform the public of an adverse drug complication Force a manufacturer to change a drugs label Enforce the removal a product from market Enforce criminal prosecution for negligent or illegal behavior 9 Drug Types The three types of drugs overseen by CDER are: 1. Prescription Drugs , those that require a doctors authorization to purchase 2. Generic Drugs , a product that is...
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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Mod3_pt1_PharmaIndustry_Lecture_2.pdf;JSESSIONIDVISTA=h8CXTnyGGw25W2TG0phyvjsZCYCKHxsycvCGV9nvccTpsh

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