In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 1-7
Abstract:
This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal for assuring the American public has access to quality medicines. At present, the new drug and generic quality assessment is performed using a written narrative. To modernize the assessment of drug applications, a KASA system has been initiated. KASA could become a system that captures and manages information about a drug product including risk identification, mitigation and communication, and control strategy. It does this through a structured IT framework that could completely replace the current unstructured text-based, narrative assessment.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v10i4.523
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2022
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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