[July 2023 Issue] FDA's Draft Guidance on OTC Drug Submissions Content/Format, PCCPs for AI/ML Devices + Warning Letter Breakdown

Welcome to Insider issue #15.

And a very warm summer welcome to the 138 new life science professionals who joined last month. If you haven’t already graduated to a paid subscription to unlock issues like this one, you can do so here.

This month, for our pharma crowd, we examine the FDA's long-awaited guidance on the content and format of OTC drug submissions. Following the enactment of the CARES Act in 2020, the FDA now has the authority to modify the conditions for “generally recognized as safe and effective” (GRASE) for an OTC monograph drug. In April 2023, the FDA released this draft guidance, which outlines how to submit an Over-the-Counter Monograph Order Request (OMOR) to the FDA. We’ll guide you through the five modules of an OMOR and lay out some action items to ensure successful submissions.

In our device feature, we look at the FDA's latest draft guidance for Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software (AI/ML). As the landscape of healthcare becomes increasingly digital and machine learning continues finding its way into all kinds of tech, managing changes in devices and software is becoming more complex. We discuss the implications of this development and provide a detailed breakdown of the PCCP as part of the device submission—an area many device and digital health firms will no doubt need to pay attention to soon if they aren’t already.

Lastly, our warning letter breakdown covers a recent case where an OTC firm in Mexico fell short of GMP. The FDA issued a warning letter to the firm for "significant violations" related to their production of an OTC product. We examine the specifics of this case and provide key takeaways that manufacturers can learn from to avoid similar compliance pitfalls.