FDA Released 21 New Guidance Documents in the Last 15 Days of 2023
(Thursday, January 4, 2024)
It has become an annual ritual for FDA to release several new Guidance Documents in the last few days of a year and true to that, the FDA did exactly that by releasing 21 new Guidance Documents in the last 13 days of December. Many of these Guidance Documents affect critical aspects of FDA regulated products so in case you missed them during the hullabaloo of the holidays, here is the summary of the standouts.
Out of 21 Guidance Documents released by the FDA in the last two weeks of December, we identified eight that in our opinion address particularly critical issues. Three new Guidance Documents deal with various aspects of real world data (RWD) for providing supporting information for the approval of drugs, biologics, and medical devices. In the last six years, FDA has published 10 guidance documents regarding use of RWD in support of market approval applications, two for medical device applications, one for veterinary products and seven for drugs and biologics. Together these guidance documents address various common questions sponsors have about FDA expectations from RWD. These guidance address FDA’s expectation of RWD originating from patient registries, data standards for RWD, and a very detailed guidance on using RWD to support medical device applications.
The new Guidance Document on Master Protocols describes the various aspects of such studies that are used to evaluate one or few drugs for multiple indications. The guidance details the design and data analysis aspects, as well as the regulatory aspects of such protocols for all products. This guidance adds to the previous guidance documents for such protocols for oncology products and cell and gene therapy products released in late 2022. The second guidance document related to clinical trials discusses key project management and regulatory considerations for remote data collection using digital health technologies.
A comprehensive new guidance document on developing drugs for rare diseases, summarizes all aspects of such programs from non-clinical to clinical and market approval considerations. This document is a good primer for new developers but may have some nuggets of useful information for experienced developers as well. Similarly, a comprehensive guidance on evaluating potency of cell and gene therapy products provides a great primer on the acceptance criteria for such assays.
A cherry on top, in one of its first Federal Register posts, FDA released a report on Good Guidance Practices that describes key processes followed by the FDA for creation new Guidance Documents and feedback it requests from the industry about improving the process for commenting on the Guidance Documents.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC