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History of FDA and Related Regulatory Agencies

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Presentation on theme: "History of FDA and Related Regulatory Agencies"— Presentation transcript:

1 History of FDA and Related Regulatory Agencies
Gretchen Bowker Pearl Pathways

2 FDA Mission Protect public health
Safety efficacy and security of approved drugs, devices, biologics, cosmetics, and food supply Advancing public health Sharing information

3 Structure of FDA CBER - Biologics, Vaccines, Blood, Cells/Genes
CDER – Drugs, Rx and OTC, Advertisements CDRH – Devices and Radiation Emitting products CFSAN – Food safety, not meat poultry & eggs CTP – Tobacco product labeling and Ads CVM – Animal Food and Drug safety and effectiveness ORA – Quality system compliance NCTR – Counter terrorism, pathogen monitoring

4 Office of Chief Counsel
Office of Special Medical Programs Combination Products Good Clinical Practice Orphan Product Development Pediatric Therapeutics

5 InterCenter Agreements
Define oversight agreements CDER reviews biologics CBER reviews devices Combination products assists with designations

6 Related Agencies FTC - false advertisement
CMS – medicare and medicaid reimbursement CPSC – product safety SEC – protect investing public OSHA – employee safety TTB – alcohol safety USDA - dairy, poultry, fruit and meat safety DOC – fish safety EPA – environment protection DEA – Illegal drugs

7 Bottom Line Know the centers and what they do
CDER CBER CDRH CFSAN ORA Know the main offices at Chief Counsel Combination products Orphan drugs

8 History of Food Drug and Cosmetic Laws
Gretchen Bowker Pearl Pathways

9 Highlights Pure Food and Drug Act 1906
Provided the original drug definition still in use Provided labeling requirements Assumed consumers would make sound decisions based on accurate labels Food, Drug and Cosmetic Act 1938 “The Act” replaced Pure Food and Drug Act Created the NDA process Legal basis for current legislation

10 After “The Act” Food beefed up by Nutrition labeling in 1990
Added Devices in 1976 Food beefed up by Nutrition labeling in 1990 Dietary Supplement Health and Education Act, aka DSHEA 1994 Bioterrorism Act 2002 Cosmetics FD&C safe colorants

11 Current Trends Orphan Drug act – Orphan drug patents and grants
Hatch-Waxman act – Patents and Generics Safe Medical Devices Act – defined a device and required post-market reporting, created HUDs PDUFA – fees for quicker reviews FDAMA – Cadre of changes for clinical study changes and device reporting

12 More Current Trends MDUFMA – fees for device submissions
PREA – required pediatric studies or a waiver FDAAA – reauthorized PDUFA, MDUFMA, PREA and added clinical FDASIA – Not mentioned in the book, but you should familiarize yourself with the concepts in your spare time………

13 Laws, Regulations and Guidance
Laws are enacted by Congress aka “The Act” Regulations are instructions on how to meet the law, they create standards aka 21CFR……. Guidance defines FDA expectations aka Guidance for Industry……

14 Regulation or Rulemaking Process
Proposed rules are published in the Federal Register Anyone can send in comments FDA can promulgate the rule, extend the comment period or abandon the rule Final rules are published in the Federal Register The public can petition to change a regulation Good luck!!

15 Bottom Line History questions are easy to test on

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