• 00:00    |    
    Initial credits
  • 00:06    |    
  • Overview
  • 05:45    |    
    Food and Drug Administration (FDA)
  • 06:36    |    
    • 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    |    
    • 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

Testing and Approval of Drugs and Medical Devices

New Media  | 14 de octubre de 2013  | Vistas: 116

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…