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 trials.gov
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