A new U.S. Food and Drug Administration (FDA) draft guidance gently reminds sponsors to list all clinical sites and entities handling clinical study–related activities when submitting New Drug Application (NDA) and Biologic License Application (BLA) data to the agency. The guidance, “Standardization Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions,” is part of the agency’s ongoing effort to standardize formatting for BIMO inspection submissions to the Center for Drug Evaluation and Research (CDER).
Those submissions must include a table displaying all clinical sites participating in clinical studies, the name of each site’s clinical investigator, its identification number and address, as well as any applicable updates to clinical investigators’ contact information.
FDA wants the submissions to list all institutions to which the sponsor has contracted any part of the clinical study process. The information should include all entities who assumed responsibility for any regulatory functions and the specific study functions for which they were contracted (e.g., site monitoring, study drug preparation and/or packaging, drug distribution and/or randomization). Submissions should also include the protocol, protocol amendments, and any annotated case report forms for pivotal safety and efficacy studies.
CDER BIMO Compliance and Enforcement: What You Need to Know—Join FDA personnel from CDER at ACRP 2018 this April as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one. Speaker David Burrow, Pharm.D., J.D., Acting Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. View Session Details
Applicants also should provide subject-level data line listings by clinical site, including studies with different treatment indications. As an example, the guidance explains that an application based on a pain trial in which subjects recorded pain scores in a diary should include the raw data, primary data points that were used to calculate the derived primary endpoint, and any other derived protocol elements.
Applicants also must include a summary-level clinical site dataset containing data from pivotal studies to support safety and efficacy claims, including independent data for each study in cases where clinical investigator sites are involved in multiple studies.
Author: Michael Causey