Drug Approval [schvalování léčiv]

topical
1 766
Terms

FDA proces schvalování léčiv
FDA schvalování léčiv
léky - schvalování
proces schvalování léčiv
proces schvalování nových léčiv
registrace léků
schvalování léku
schvalování léků
schvalování nového léku
schvalování nových léků

 

Drug Approval Process
Food and Drug Administration Drug Approval
Food and Drug Administration Drug Approval Process
New Drug Approval
New Drug Approval Process

Persistent link   https://www.medvik.cz/link/D017277
Definition

Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

Annotation
by govt regulatory agency, U.S. (not restricted to FDA) or foreign
vládní regulační agenturou USA (není omezeno na FDA) nebo zahraničními
DUI
D017277 MeSH Browser
CUI
M0026229
History note
93
Public note
93

E Analytical, Diagnostic and Therapeutic Techniques and Equipment
E05.290 Drug Development 136
E05.290.250 Drug Approval 1 766
E05.290.250.199 Compassionate Use Trials 4
E05.290.563 Drug Discovery 350
E05.290.625 Drug Evaluation 5 288
E05.290.875 Drug Repositioning 127
E05.337.275 Device Approval 264
E05.337.300 Drug Approval 1 766
E05.337.300.199 Compassionate Use Trials 4
E05.337.425 Drug Evaluation 5 288
E05.337.675 Feasibility Studies 224
E05.337.737 Pilot Projects 1 774
E05.337.820 Program Evaluation 300

I Anthropology, Education, Sociology and Social Phenomena
I01.880 Sociology 777
I01.880.604 Social Control, Formal 127
I01.880.604.605 Legislation, Drug 791
I01.880.604.605.250 Drug and Narcotic Control 964
I01.880.604.605.250.250 Drug Approval 1 766
I01.880.604.605.250.625 Drug Recalls 145
I01.880.604.605.250.812 Safety-Based Drug Withdrawals 78