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[December 2023 Issue] FDA Updates Policies for Reviewing ANDAs, Details 510(k) Modernization with Trio of Draft Guidances + Warning Letter Breakdown

We dive into a new MAPP on ANDA review, parse all the updates to the 510(k) program, and look at two warning letters for failing to respond to record requests.

Welcome to Insider issue #20.

And a very warm welcome to the 428 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.

In our pharma segment, we discuss the FDA's latest overhaul of its manual for reviewing Abbreviated New Drug Applications (ANDAs). Marking the first update since 2017, these changes are designed to streamline the ANDA approval process. As part of the reauthorized generic drug user fee program, the FDA aims to minimize review cycles for ANDA approvals, enhancing efficiency in generic drug availability.

We dissect the three key amendments in the FDA's approach, from adopting new assessment templates to refining the roles of assessors and division directors, and the importance of clear communication in addressing deficiencies for ANDA approval. We give insight into each module's significance, from administrative information to clinical data evaluation. Recognizing the nuanced nature of these submissions, we suggest practical action items for companies to align with these updates, such as adopting new templates, focusing on high-quality submissions, and efficiently managing amendments and reconsiderations.

In our device/medtech segment, we analyze the FDA's latest guidances aimed at modernizing the 510(k) program, which plays a critical role in ensuring medical device safety. The first guidance offers best practices for selecting predicate devices, the second outlines circumstances necessitating clinical data, and the third provides comprehensive recommendations for 510(k) device performance testing. These guidances reflect the FDA's commitment to advancing medical device safety and efficacy. We offer targeted action items for companies to align with these new guidances, from aligning device types with FDA-identified performance criteria to implementing the eSTAR program for 510(k) submissions.

Finally, we turn our attention to a recent FDA enforcement action involving warning letters issued to two firms for failing to respond to record requests. These cases highlight the critical importance of regulatory compliance and responsiveness. We provide takeaways and lessons for similar firms, emphasizing the need for prompt responses to regulatory requests, regular internal audits, rigorous testing protocols, and keeping FDA registrations and drug listings up to date.

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The FDA Group