00:00    |    
Initial credits
00:06    |    
Introduction
Overview
05:45    |    
Food and Drug Administration (FDA)
06:36    |    
History
Safety in agricultural foodstuff and medicines (1800)
Emphasis on regulation of product labeling (1906)
Control to medical devices and drug approval (1938)
Prescription and over-the-counter drugs (1951)
Approval for drugs efficacy (1962)
Was thalidomide disapproved because of safety or efficacy?
Data revision before medical device marketing (1976)
New laws for speeding up testing (1980-2000)
17:14    |    
Authority
Cosmetics
Drugs and devices
Does a small baker need approval from the FDA?
23:59    |    
Drug and device development
Preclinical stage
Clinical testing stage
FDA approval
29:03    |    
Clinical testing
Phase 1: Safety and toxicity
Do people volunteer to test the drugs at phase 1?
Is this process after or alongside you've developed the drug?
Phase 2: Safety, proof of concept, dose selection
Phase 3: Safety and efficacy
Clinical research
37:22    |    
FDA and medical device approval
Classification
What about noninvasive devices?
Is the PEAK PlasmaBlade System a high-risk device?
Data packages needed for approval
42:32    |    
FDA and drug approval
New chemicals
Generic drugs
Old drugs, new use
44:43    |    
European regulation
Devices
Drugs
50:47    |    
Criticisms on current approval system
Increasing testing requirements
Different thoughts on pre-approval testing
Speed to approval
Ease of access to investigational drugs
Efficacy of medical devices: USA versus EU
Advertising
Clinical trial designs
Comparison of drug to placebo
58:22    |    
Questions and answer period
Do they keep the study subjects' files open for observation during their life?
Is it possible to launch a product to the market while continuing its observation?
How does the United States regulate exported and imported drugs?
How does the FDA apply the first amendment to nutraceuticals and dietary supplements?
If vitamine E is not officially regulated by the FDA and there is peer-reviewed research, why would there be any problems?
Who watches over the FDA?
What about the cases of small companies being shut down by the big pharmas with the help of FDA scientists?
What kind of health criteria does the FDA use to approve food?
Coke example
What are the risks and benefits of allowing drugs for the terminally ill who bypass stage three of clinical trials?
Would the FDA approve more easily a drug if there is a case of an epidemic or any other emergency situation?
01:16:09    |    
Final credits



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Testing and Approval of Drugs and Medical Devices

14 de octubre de 2013   | Vistas: 59 |  

Ann C. Tunstall talks about the Food and Drug Administration (FDA), how it began and how its attributions have been changing through time. She explains how drugs and medical devices are approved by this institution and comments on the three phases for clinical testing on drugs: safety and toxicity; safety, proof of concept and dose selection; and safety and efficacy. She also shares the differences between the United States and the European regulation for medicine and the critics the FDA regulary receive for its strict laws of approval.




Ann C. Tunstall is a biological engineer, she provides strategic insight into the research, development, and evaluation of novel pharmaceuticals,…

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