USA – FDA published a Draft Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
Year: 2024
Type: other
Abstract: This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this guidance) made to licensed biosimilars and licensed interchangeable biosimilars. This question-and-answer (Q&A) guidance is intended to inform prospective and current applicants of the nature and type of information that applic...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12jaj
Author: Vroby
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6918016362
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