Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. Following comments from FDA, USP announced that it would not make any changes absent stakeholder consensus. Last month, USP…
USP stated last week that it will not develop new product-specific monographs for biologics without stakeholder consensus in supporting their creation, including the support of FDA. USP had proposed revisions for these monographs in which “the official title shall be the title specified in the relevant monograph plus any suffix…