FDA Regulations Overview and Scope

The FDA regulates research involving drugs, devices, supplements, botanicals, and biologics. Understand what falls under FDA regulations and what doesn't, the unique aspects of FDA regulations, and the importance of compliance in ensuring safety and efficacy of medical products.

• FDA regulations
• research
• drugs
• devices
• compliance

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Uploaded on Feb 20, 2025 | 0 Views

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Presentation Transcript

1. FDA Basics 21 CRF 50 Protection of Human Subjects 21 CFR 56 - IRBs

2. So, what is FDA regulated? Conducting research with drugs, devices, supplements, botanicals, or biologics Includes those that have received FDA approval as well as investigational items

3. Some examples of NOT FDA regulated Medical record reviews Cost effectiveness and quality improvement activities Drug and device registries Studies of surgical techniques that are only evaluating a new technique

4. The FDA regulations are different Human subject not defined by identifiability Means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.

5. The FDA regulations are different Research = clinical investigation Means any experiment that involves a test article and one or more human subjects

6. The FDA regulations are different Engagement? Nope. Screening Activities? Nope. Waivers? Yes, but limited. Recently allowed for a waiver of consent for minimal risk studies (akin to HHS) Did not sign on to the 2018 Requirements

7. Why such a large scope? The Food, Drug, and Cosmetic Act ("FD&C Act") generally prohibits the manufacture, delivery, use, receipt or sale of any drug or device that is "adulterated" or "misbranded To avoid civil and even criminal sanctions for adulteration or misbranding, an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) may be required It s about interstate commerce and getting item to market

8. Start with the assumption that any research involving a drug, medical device, biologic, or supplement is subject to FDA regulations

9. FDA mantra Does it involve an item ? Drug Drug (a substance (other than food) intended to affect the structure or any function of the body ) Device(an instrument, apparatus, implement, machine intended for use in diagnosis of disease or other conditions ) Supplement (product (other than tobacco) that is intended to supplement the diet ) Botanical(finished, labeled product that contains vegetable matter ) Biologic (virus, therapeutic serum, toxin, vaccine) Device Supplement Botanical Biologic

10. FDA mantra Is it FDA regulated? Clinical investigation Includes human subjects (just say yes to this if FDA regulated) USE USE- WORKSHEET: Human Subjects Research (whether IRB review is needed) USE USE- WORKSHEET: Human Subjects Regulations (whether FDA regulations apply)

11. Questions?