Importance of Cover Letters in Directing FDA Staffs’ Review of Applications
(Thursday, September 15, 2022)
IND, NDA and BLA submissions containing real-world data and real-world evidence (RWD/RWE) should highlight that info in the cover letter to that submission, according to the latest FDA guidance on best practices for the using such data to support claims in an application. While the guidance may seem mundane to an untrained eye, this highlights the critical importance of cover letters in submissions made to the FDA. A cover letter is generally assumed to be a mere formality since these are not well defined in the regulations or guidance documents, and their purpose is not clear. Cover letters generally contain barebone information about a given submission with usually just a high-level description of the content of the submission. But this latest guidance document describes the details expected in the cover letters for submissions containing RWE/RWD. Specifically, the guidance recommends that in the cover letter, the sponsor should include the specific purpose of the RWD/RWE, description of the study design using RWD to generate RWE, and the source of the RWD used to generate RWE. The guidance also provides a checklist to the sponsors to refer when including information about RWD/RWE in their cover letters. This information would be used by the project management staff at FDA to track applications containing RWD/RWE. For the last 10+ years, FDA has gradually strengthened its project management departments across all centers to streamline the review of various applications. The PM staff, who although may not be directly involved in the review of the application content, plays a critical role in tracking the applications inside FDA, coordinating with the review staff, and collating the progress of FDA’s various programs. The cover letters are an important way for the PMs to be aware of the contents of a submission without needing to review the complete content of that submission. It is important for sponsors of applications to give an appropriate respect to the cover letter. This guidance should provide a window into FDA’s internal project tracking processes. A cover letter is not a formality but an essential component of an application.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC