The US Food and Drug Administration (FDA) has finalized guidance for sponsors on electronically submitting data on drugs and biologics that the agency will use when conducting bioresearch monitoring (BIMO) inspections. The guidance details the standardized formats that should be used when submitting such data.
The guidance finalizes a draft version that was released for comment in February 2018. The document addresses the agency’s thinking on the kinds of data its Center for Drug Evaluation and Research (CDER) needs from major studies conducted to support certain premarket submissions for drugs and biologics. More specifically, the guidance applies to new drug applications (NDA), biologics license applications (BLA), certain supplemental applications, and certain investigational new drugs (IND)…
