November, 24 2020
The FDA has published a draft guidance containing Additional Q&As on Biosimilar Development and the BPCI Act
, which after finalization, will be added as a revision to final Q&As on biosimilar development. Four Q&As (I.25 to I.28) have been added to provide clarity regarding the submission & labelling requirements of interchangeable biosimilar products.
About CBCC Global Research
At CBCC Global Research, we are accelerating medical therapy development by providing high quality, affordable and innovative solutions.
We provide strategic solutions for all phases of clinical trials through efficient delivery of services for the flawless execution of projects, on time – every time.
We are committed to achieving excellence in all research projects by ensuring scientific validity, data integrity, and compliance with the latest regulatory guidelines, thus striving to be a leading global clinical research organization (CRO).