On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current...more
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval...more
In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more
On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate...more
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more