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Descriptor English: Drug Approval
Descriptor Spanish: Aprobación de Drogas
Descriptor autorización de medicamentos
Entry term(s) autorización de nuevos medicamentos
proceso de aprobación de medicamentos
proceso de autorización de medicamentos
Scope note: Proceso al que ha de someterse un fármaco para que reciba la aprobación por parte de una agencia gubernamental reguladora. Incluye cualquier prueba preclínica o clínica, revisión, presentación y evaluación de las solicitudes y de los resultados de las pruebas, así como la vigilancia del fármaco después de la comercialización.
Descriptor Portuguese: Aprovação de Drogas
Descriptor French: Agrément de médicaments
Entry term(s): Approval Process, Drug
Approval Processes, Drug
Approval, Drug
Approval, New Drug
Approvals, Drug
Approvals, New Drug
Drug Approval Process
Drug Approval Processes
Drug Approval, New
Drug Approvals
Drug Approvals, New
Food and Drug Administration Drug Approval
Food and Drug Administration Drug Approval Process
New Drug Approval
New Drug Approval Process
New Drug Approvals
Process, Drug Approval
Processes, Drug Approval
Tree number(s): E05.290.250
E05.337.300
I01.880.604.605.250.250
VS2.002.003.001
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D017277
Scope note: 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
Allowable Qualifiers: EC economics
HI history
LJ legislation & jurisprudence
MT methods
OG organization & administration
SN statistics & numerical data
Public MeSH Note: 93
History Note: 93
Related: Drugs, Investigational MeSH
DeCS ID: 30745
Unique ID: D017277
NLM Classification: QV 771
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 1993/01/01
Date of Entry: 1992/05/20
Revision Date: 2018/06/29
Drug Approval - Preferred
Concept UI M0026229
Scope note 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.
Preferred term Drug Approval
Entry term(s) Approval, Drug
Approvals, Drug
Drug Approvals
Food and Drug Administration Drug Approval
Drug Approval Process - Broader
Concept UI M0026227
Preferred term Drug Approval Process
Entry term(s) Approval Process, Drug
Approval Processes, Drug
Drug Approval Processes
Process, Drug Approval
Processes, Drug Approval
New Drug Approval Process - Narrower
Concept UI M0026226
Preferred term New Drug Approval Process
New Drug Approval - Narrower
Concept UI M0026228
Preferred term New Drug Approval
Entry term(s) Approval, New Drug
Approvals, New Drug
Drug Approval, New
Drug Approvals, New
New Drug Approvals
Food and Drug Administration Drug Approval Process - Narrower
Concept UI M0026225
Preferred term Food and Drug Administration Drug Approval Process



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