Mintz

AI misuse in drug manufacturing has triggered its first warning letter, an early signal the FDA is scrutinizing how AI is being used by regulated entities. This is one of several developments highlighted in the latest FDA in Flux newsletter.

• Proof-of-concept “real-time clinical trials” are now underway, with sponsors submitting endpoint data through digital platforms. These pilots signal a shift toward AI-enabled trial models designed to compress development timelines and move toward more continuous approaches.

• Scrutiny of drug compounding continues to intensify, including a proposal to exclude certain GLP-1 active ingredients from the 503B ingredient list and upcoming advisory meetings to evaluate certain experimental peptides for use by 503A compounders. These developments reinforce the current legal framework and the importance of compliance across 503A and 503B compounders.

• FDA is asking stakeholders to help identify drugs for potential repurposing where scientific data exists creating potential opportunities in underserved and rare disease areas.

• A new citizen petition challenges FDA’s disclosure of complete response letters and highlights the potential risks to proprietary information and competitive positioning.

Read the full issue: https://bit.ly/4v1DxnY