|
TERM |
COUNTRY |
DEFINITION |
|
483 |
US |
Written observations of deviations from GLP, GCP or GMP regulations
found during an FDA inspection |
|
510(k) |
US |
Pre-market Notification to commercialize class I and class
II devices |
|
ANDA |
US |
Abbreviated New Drug Application |
|
ANDA Suitability Petition |
US |
Petition to allow submission of an ANDA for a drug that differs
from the reference listed drug in certain specified ways |
|
ANDS |
Canada |
Abbreviated New Drug Submission |
|
CBER |
US |
Center for Biologics Evaluation and Research |
|
CDC |
US |
Centers for Disease Control |
|
CDER |
US |
Center for Drug Evaluation and Research |
|
CDRH |
US |
Center for Devices and Radiological Health |
|
Compassionate Use |
US |
Permission to treat individual patients with an unapproved drug |
|
CSM |
UK |
Committee on Safety of Medicines |
|
CTC |
UK |
Clinical Trial Certificate |
|
CTX |
UK |
Clinical Trial Exemption |
|
DMF |
All[1] |
Drug Master File |
|
FDA |
US |
Food and Drug Administration |
|
GCP |
All |
Good Clinical Practice Regulations |
|
GLP |
All |
Good Laboratory Practice Regulations, as described in 21
CFR 58, for the conduct of a non-clinical laboratory study |
|
GMP |
All |
Good Manufacturing Practice Regulations |
|
HPFB |
Canada |
Health Products and Food Branch |
|
ICH |
All |
International Conference on Harmonisation (effort to harmonize
regulations affecting the development and approval of drugs in the
European Union, Canada, US and Japan) |
|
IDE |
US |
Investigational Device Exemption |
|
IND |
US, Canada |
Investigational New Drug Application |
|
MAA |
UK |
Marketing Authorisation Application |
|
MCA |
UK |
Medicines Control Agency |
|
Named Patient Use |
UK |
Permission to treat individual patients with an unapproved
drug |
|
NCI |
US |
National Cancer Institute |
|
NDA |
US |
New Drug Application |
|
NDA Supplement |
US |
Supplement to an approved NDA |
|
NDS |
Canada |
New Drug Submission |
|
NIH |
US |
National Institutes of Health |
|
OGD |
US |
Office of Generic Drugs |
|
Orphan
Drug |
US |
Drug intended for use in a rare disease or condition as defined
in section 526 of the Orphan Drug Act |
|
PMA |
US |
Pre-market Authorization for approval of class III devices |
|
SOP |
US |
Standard Operating Procedure |
|
USAN |
US |
United States Adopted Names |
|
USP |
US |
United States Pharmacopeia |