Coming to America – Successfully Tackling the FDA Landscape

The regulatory landscape for the development of drugs and biologics is continually being updated and guidelines differ significantly, so many pharmaceutical/biopharmaceutical companies successfully developing and marketing products in their own countries must navigate through FDA requirements to seek US licensure for marketing.

It is essential to consult the updated guidance documents and interact with the FDA during the drug development process and to have support from an experienced regulatory partner to ensure that FDA expectations will be met when the drug/biologic applications are filed.

In this article our Linical Americas colleagues Dr. Kamali Chance and Dr. Tracy Goeken review US regulatory pathways for drugs and biologics, as well as FDA expectations for chemistry, manufacturing, and controls (CMC), nonclinical and clinical development.

Click on the image to access full article*

*Originally published on International Clinical Trials November 2021, pages 53-58. (© Samedan Ltd)