Thailand FDA Enhances Drug Labeling and PIL Rules: New …
On August 20, 2024, the Food and Drug Administration (FDA) of Thailand issued an important update to the guidelines for electronically submi…
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FDA Guidance on Developing Chimeric Antigen Receptor (C…
The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products. Focused on s…
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NPRA published Guidance Document and Guidelines for Reg…
The NPRA has released a revised edition of the biosimilar product registration guidelines in the second edition of the Guidance Document and…
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US FDA Releases Draft Guidance on Translation for Good …
This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that t…
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