USA – FDA issues draft guidance covering BIMO inspections

The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the agency in planning these inspections, while the second covers best practices for communicating to the FDA before, during, or after an inspection. Both cover sponsors that have submitted new drug applications (NDAs), biologics license applications (BLAs), and supplements. More information on the Regulatory Focus Website.

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2024-10-19
DOI
https://doi.org/10.58079/12ja0
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.00
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article

USA – FDA issues draft guidance covering BIMO inspections

Industrias Culturais (Universidade de Coimbra)
Biosimilars and Bioanalytical Methods
article

USA – FDA issues draft guidance covering BIMO inspections

article en

Abstract

The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the agency in planning these inspections, while the second covers best practices for communicating to the FDA before, during, or after an inspection. Both cover sponsors that have submitted new drug applications (NDAs), biologics license applications (BLAs), and supplements. More information on the Regulatory Focus Website.

Industrias Culturais (Universidade de Coimbra)
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Openalex Percentile: Top 51%
Biosimilars and Bioanalytical Methods
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USA – FDA issues draft guidance covering BIMO inspections · Industrias Culturais (Universidade de Coimbra) (2024) | TGRS Research Map | TGRS