FDA finalizes BIMO electronic submission guidance

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).

“To meet its review performance goals in accordance with CDER good review management principles and practices for products covered by the Prescription Drug User Fee Act (PDUFA), CDER generally initiates inspection planning early in the application review process (i.e., during the filing determination and review planning phase),” said FDA. “CDER's inspection planning includes the selection of clinical investigator sites and other regulated entities for on-site inspections, and the preparation of assignment memos and background packages that CDER provides to [Office of Inspections and Investigations (OII)] investigators, who perform FDA's BIMO inspections.”

“CDER uses the data and information described in this guidance to plan BIMO inspections, including: (1) to facilitate the timely identification of sites for inspection and (2) to ensure the availability of information needed to conduct BIMO inspections by OII investigators,” the agency added.

When the draft guidance was published, the FDA received six comments, including comments from the Pharmaceutical Research and Manufacturers of America (PhRMA). The industry group argued that much of the information requested by the FDA in the BIMO plans is redundant and already available in the electronic Common Technical Document (eCTD). It said that asking for resubmitting the information would be a significant burden on sponsors.

“PhRMA fully supports FDA’s efforts to protect patient safety through the conduct of preapproval clinical site inspections, and therefore would be concerned with inefficiencies that would result from the requirements to create and submit duplicative information,” said the lobby group. “Such policies and practices divert resources, unnecessarily increase the burden on sponsors to comply with regulatory requirements, and may delay the conduct of the inspections necessary to bring new medicines to patients.”

FDA acknowledged PhRMA’s concerns and directed sponsors to submit certain information only in the eCTD.

“[FDA] deleted specific directions related to eCTD formatting and optional submission of a BIMO Reviewer's Guide and clarified that specifications for these items are now included in the technical specifications document,” said the agency. “Additional comments received, which were related to the technical specifications document ‘Bioresearch Monitoring Technical Conformance Guide,’ have been addressed separately in prior revisions to that document.”

FDA also clarified which NDA and BLA supplements fall under the guidance. Furthermore, it added that clinical sites that screened, consented, or enrolled trial participants need to be included in a table that lists all the clinical sites that were part of the clinical studies.

FDA also updated the final guidance by requiring sponsors to provide a list of all entities they used to conduct clinical trial-related activities. The list should encompass not only entities to which regulatory obligations have been transferred but also those to which such obligations were not transferred.

Final guidance

FDA finalizes BIMO electronic submission guidance

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