PRODUCT REGULATIONS

https://www.hhs.gov/about/agencies/orgchart/index.htm
l https://www.fda.gov/about-fda/fda-organization/fda-organization-charts
https://www.fda.gov/about-fda/what-we-do
https://www.fda.gov/science-research/advancing-regulatory-science/centers-excell
ence-regulatory-science-and-innovation-cersis#:~:text=FDA's%20Centers%20of%
20Excellence%20in,%2C%20training%2C%20and%20scientific%20exchanges
.
CBER - center for biologics evaluation and research
CDER- center for drugs evaluation and research
CDRH - center for devices and radiological health
TRAGEDIES LEAD TO LEGISLATIVE AND REGULATORY ACTIONS

TETANUS 1901 - BIOLOGICS CONTROL ACT 1902

CURE ALL CLAIMS - FOOD AND DRUG ACT 1906
100 DIE DIETHYL GLYCOL - FEDERAL FD&C ACT 1938
CUTTER INCIDENT SALK VACCINE 1955 - DIVISION OF BIOLOGICAL
STANDARDS-NIH
THALIDOMIDE - KEFAUVER HARRIS DRUG AMENDMENTS 1962
CYANIDE 1982 - FEDERAL ANTI TAMPERING ACT 1983
STATUTARY AND REGULATORY AUTHORITIES
FD&C ACT
PUBLIC HEALTH SERVICE AC
INTERSTATE COMMERCE
FOREIGN COMMERCE
GENETIC EUIVALENCE
GMP
PDUFA
FDA MA 1997
BIOLOGICS PRICE COMPETITION AND INNOVATION 2010
FOOD AND DRUG ADMINISTRATION SCIENCE AND INNOVATION ACT
(FDASIA) 2012 - user fees
Discovery pre-clinical - Pre-IND
Submit IND IDE investigational new drug, investigational device exemption
Clinical development
Phase 1 2 3
IND review
Submit BLA NDA PMA biologics license application, new drug application, premarket approval
BLA issues
MARKETING , phase 4
Post approval issues
Submit SUPPLEMENTS
REGULATIONS FOR MEDICAL PRODUCTS TITLE 21 CFR

201, 202 - LABELLING AND ADVERTISING

312 IND
314 NDA
600-680 BIOLOGICS
800-861 DEVICES AND INVITRO DIAGNOSTICS
25 - environmental impact considerations
50 - protection of human subjects
54 financial disclosure of clinical investigators
56 - institutional review boards
58 GLP
RELATIONSHIPS
LAWS
REGULATION period of comment and notice
GUIDANCE not a requirement, period of comment and notice
EXTERNAL STANDARDS
POLICIES PRECEDENTS

SCIENCE - RISK - LAW

21 CFR 312 GCP ICH E6
QUALITY and safety issues - manufacturing
biological products
cGMP meant for marketing
Phase 1 exempt from 211 regulations
Pharmacology and tox considerations
Clinical considerations
Trials

IND safety reports 21 cfr 312.32

Suspected adverse reaction
Annual reports
Pediatirc research equity act 2007
Fda safety and innovation act 2012
Bioreserch monitoring of fda
Expedited programs
Fast track, break through, accelerated approval, priority review
Orphan drugs 21 cfr 316
Standards of licensure
SAFETY
PURITY
POTENCY
STABILITY
PRODUCT QUALITY
CGMP compliance
Post marketing surveillance and compliance
Adverse event reporting 21 cfr 600.80
Inspections
Enforcement
Education
upcoming
Adaptive clinical trial design
Biomarkers - omics
Demographic subgroups
Big data
Structured data
Combination products
CDISC