Cargando…

The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars

The US FDA’s new guideline suggests using “Generally Accepted Science Knowledge” (GASK) to develop nonclinical testing protocols for developing drugs and biologicals to remove unnecessary testing. Interpreting acceptable scientific knowledge as a rational approach has motivated the author to suggest...

Descripción completa

Detalles Bibliográficos
Autor principal: Niazi, Sarfaraz K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10674418/
https://www.ncbi.nlm.nih.gov/pubmed/38004383
http://dx.doi.org/10.3390/ph16111517