Biologics

It is likely that you know someone who has received a ligament or tendon replacement, a cornea transplant, or a skin graft. If these tissues were derived from humans, are these products regulated by FDA? This blog will provide an overview of the regulatory framework...

In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests. Upon completion...

In the past, FDA’s guidance on post approval changes made to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Chemistry Manufacturing and Controls (CMC) has been ambiguous and hindered continuous improvement of pharmaceutical manufacturing processes. NDA and ANDA holders are expected to perform...