policy practice and regulatory rules Flashcards
1
Q
act that authorizes hospitals and retailers to become collector sites
A
safe and secure drug disposal act of 2010
2
Q
expedited the availability of generic drugs; allows 6 months of generic exclusivity
A
Hatchman waxman act
3
Q
when does inda get applied for
A
after preclinical before phase I
4
Q
form 3500A for Medwatch
A
mandatory reporting for clinical studies and in regulated industry and device user such ash osptials and nursing homes
5
Q
USP 795
A
non sterile compounding
6
Q
usp 797
A
sterile compounding
7
Q
usp 800
A
hazardous
8
Q
BCPI ACT
A
biologics competition and innovation act: abbreviated licensure pathway for biological products found to be biosimilar; w/ FDA approved reference after 12 years of patent exclusivity
