FDA office of commissioner - ANSWER top office
senate confirmation
overall agency coordination
Food and Vet medicine (baby food animals)
Global reg. operations and policy (reg stuff)
Chief scientest (tox reserach
FDA office of commissioner - ANSWER top office
senate confirmation
overall agency coordination
Food and Vet medicine (baby food animals)
Global reg. operations and policy (reg stuff)
Chief scientest (tox reserach)
Med products and tobacco
(biologics, CDER, Devices, tobacco)
ALL under FDA-
FDA funded through - ANSWER annual discretionary approprations, if you dont
use it its okay
,user fees reauthorized every 5 years (from meds, generics biologics, devices) goes
back to funding for Center for biologics research and CDER.
FDA office of chief counsel - ANSWER legal affairs
Title 21 - ANSWER food and drugs
-- has the standards for IRB composition and responsibilities
controlled substance
Title 42 - ANSWER public health- Departmnet of health and human services, CMS.
PURPLE BOOK (instead of orange book) - ANSWER Biological products and bio
similar interchangeables
clinical trial - ANSWER research study of humans conducted to answer specific
questions about:
vaccines
new therapies
new ways to use know treatments
determine whether new drugs are safe and effective
INDA - ANSWER investigational new drug application
used for new drug, new indication, off label use. You need INDA to start Phase 1
trials.
sometimes pre-clinical trials includes lab/animal/tox testing for use in INDA
, allows new drug to be dist across state lines before full FDA review
NDA - ANSWER new drug application
formal proposal that FDA approve new pharmaceutical for sale and marketing in
US
drug importation act of 1848 - ANSWER prohibited the importation of unsafe or
adulterated drugs at key points of entry
food drug and cosmetics act of 1938 - ANSWER gotta show safety
advertising under FTA
usp/NF as official "compendia of drug standards"
USP and NF official standards - ANSWER food and drug act
advertising under federal trade commision - ANSWER Food drug and comsetics act
FDA to regulate advertising and establish GMP - ANSWER Kafeuvir Harris
amendments
pure food and drug act of 1906---NOTE not importation but COMMERCE -
ANSWER prohibited interstate COMMERCE: of adulterated or misbranded drugs
required labeling of selected dangerous and addictive substances
identified USP and NF as official standards
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