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India CDSCO News: Clinical and Bioequivalence Procedures for Regulatory Efficiency
Last week, two pivotal updates were introduced: the Union Health Ministry proposed major amendments to the New Drugs and Clinical Trials...

Sharan Murugan
Sep 92 min read
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USFDA Guidances: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment, Other Quality-Related Considerations & Classification Categories for Certain Supplements
In 08 September 2025, the U.S. Food and Drug Administration (FDA) issued two final guidances addressing critical aspects of biosimilar...

Sharan Murugan
Sep 92 min read
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Swissmedic Guidances: Strengthening Regulatory Clarity for Medicinal Products
On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

Sharan Murugan
Sep 72 min read
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