The U.S. Food and Drug Administration (FDA) recently released a podcast on biosimilars, featuring Dr. Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), that seems to indicate a potential...more
Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand...more
On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development and assessment of applications for...more
Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final guidance supersedes FDA’s...more