From Bench to Bedside: Getting New Drugs Approved by the FDA ( Publisher's URL )
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 Material Information
Title: From Bench to Bedside: Getting New Drugs Approved by the FDA
Physical Description: Poster
Creator: Jesano, Rae
Publisher: Smathers Libraries
Publication Date: 2006
Abstract: Poster depicts the FDA's approval process a drug must go through before it is approved for use.
Acquisition: Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Rae Jesano.
Publication Status: Unpublished
 Record Information
Source Institution: University of Florida Institutional Repository
Holding Location: University of Florida
Rights Management: All rights reserved by the submitter.
System ID: IR00000462:00001


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* It takes 12 to 15 years to develop a single drug
* Only 1 in 10,000 potential medications makes it completely through the process
* Only 5 in 5,000 (est.) possible formulations make it to human testing and out of these only
1 in 5 make it through the clinical test phase and FDA approval
* In 2000 it cost more than $800 million to develop a single drug for the market
* An estimated $51.3 billion were spent by the biopharmaceutical industry on developing
new drugs in 2005

Center for Drug Evaluation and Research (CDER)
* Approves and regulates drugs or pharmaceuticals
* Approves generics
* Maintains a system for reporting adverse events or reactions
* Checks bioequivalency to the name brand (e.g., do they react in the same way?)
* Only 1 in 20 new drugs make it through to full approval
* In 2005:
- Approved 80 new medicines (78 drugs and 2 biologics)
- 20 were totally new medicines which were never marketed in any form (15 were
priority approvals)
- Priority approvals are used for drugs that represent significant improvement over current
therapies for life-threatening diseases
- Approved 344 generic versions of drugs
* Medwatch
- Warnings and safety information
* Maintains websites with information for consumers
~ Drug safety and information sheets website htm
Center for Devices and Radiological Health
* Approves and regulates medical devices
* Oversees research in gene therapy
Center for Biological Evaluation & Research (CBER)
* Regulates Biologics including vaccines and blood
Center for Veterinary Medicine regulates veterinary pharmaceuticals
* Publishes List of Approved Animal Drug Products (Green Book)

Researchers must submit an Investigational Drug Application (IDA)

Investigational New Drug Application Process (IND) :
* Must be completed and submitted to FDA before clinical trials
* If not disapproved within 30 days Phase I Clinical Trials can begin
* The IND includes:
- Results of preclinical studies
~ Chemical formulations tested
- Computer models and/or laboratory assays to check chemical actions of formulas
- Test: Add each compound to enzymes, cell cultures or cellular substances to see ifI
- Manipulate the chemical structure of the compound until the desired reaction occur
- Test results in animal models:
* How the compound is absorbed by or reacts in the body
* Toxicological or toxicity of compound
* Is it safe to administer to human test subjects?
- Complete information on the formulation and manufacturing
- Detailed protocols for proposed clinical trials
- Progress reports on clinical trials must be sent to the institution's IRB and FDA anni
FDA can halt the clinical trials if:
* Trial's design does not meet the study's objectives
* Unsafe to administer new drug to humans or other safety issues for participants
FDA provides manual of regulations investigators must follow when running clinical trials
Clinical Trial Phases:
* FDA inspects trial sites to ensure the safety of the volunteer patients and the integrity an
* Inspects 300 to 400 clinical investigators annually
* Phase I (6 months to 1 year):
- 20 to 100 Healthy participants are given the drug to check safety in humans
* Phase II (6 months to 1 year):
- 100 to 500 patients who have the disease are given either placebo or drug to check 1
- Still checking for adverse or toxic reactions in humans and optimum dosing
� Phase III (1 to 4 years):
- Large-scale testing on 800 to 5,000 volunteer patients at multiple sites
- Randomized controlled trial (some patients get placebo instead of drug)
- Effectiveness and safety in a large, varied population
- Interactions with other medications
* Phase IV Trials (After New Drug Application is approved)
- FDA may request these studies after the new drug has been approved and is availat
~ Studies adverse effects or safety, optimal use and efficacy

1. J.A. DiMasi, R.W. Hansen, and H.G. Grabowski, "The Price of Innovation: New Estimates of Drug Develo
Health Economics 22 (2003): 151-185.
2. From Test Tube to Patient. FDA Consumer. FDA Center for Drug Evaluation and Research. Fourth Editic
Oct. 16, 2006) available at
3. CDER Report to the Nation: 2005: Improving Public Health Through Human Drugs. Center for Drug Eval
Oct. 16, 2006) available at
4. PhRMA (Pharmaceutical Research and Manufacturers Association ) Website. (cited Oct. 16, 2006) avail
httn'//www nhrm; nrn/innnvqtinn/

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