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Oct 3, 20211 min read

USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and...

Oct 3, 20211 min read

FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance

USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...

Sep 23, 20211 min read

USFDA finalizes Q&As on Biosimilar Development

US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...

Aug 8, 20211 min read

Guidance’s on GMP for Investigational Products & for R&D facilities -WHO

World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...

Aug 8, 20211 min read

Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA

USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...

Jun 27, 20211 min read

Guidance on CMC Changes to an Approved Application- US-FDA

FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...

May 8, 20211 min read

Guidance on the Licensing of Biosimilar Products - United Kingdom (MHRA)

What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...