Regulatory Blog

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...

Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...

This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when...

The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...

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

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

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

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

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

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

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