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[February 2024 Issue] FDA Finalizes Guidance on DSCSA Verification Systems, a Closer Look at FDA's Proposed LDT Rule + Warning Letter Breakdown

We dive into the FDA's final guidance on DSCSA verification systems, lay out what the agency's proposed LDT rule could mean for labs, and dissect a CGMP warning letter.

Wqelcome to Insider issue #22.

And a very warm welcome to the 392 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.

Our pharma feature focuses on the Drug Supply Chain Security Act (DSCSA), with the FDA finalizing pivotal guidance on verification systems. This update, issued on December 7, lays down the procedures for trading partners to identify, quarantine, and investigate suspect or illegitimate products. We dissect the nuances of this guidance, highlighting the essential revisions from its 2022 draft and its practical implications on trading partners.

Moving to medtech, we explore the FDA's prospective shift in the landscape of LDT regulation. On September 29, the FDA proposed a rule that could potentially end the long-standing enforcement discretion for LDTs. This proposed regulation, treating LDTs as IVDs subject to medical device regulatory requirements, suggests a phased approach to compliance. We provide a thorough breakdown of the proposed rule, detailing its phased compliance stages and the anticipated impact on laboratories offering LDTs.

Lastly, we turn our focus to a recent FDA warning letter addressed to an Indian pharmaceutical giant over CGMP violations linked to its albuterol sulfate inhalation aerosol product. We dive into the critical details of the warning letter, highlighting the company's failure in addressing customer complaints, contamination controls, and oversight of CGMP records.

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The FDA Group