As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read about the Q4 2024 updates here.

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read about the Q3 2024 updates here.

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program inspections, but very much translatable to any Form FDA 483 response. FDA notes the following best practices:

A response should demonstrate the establishment’s acknowledgment and understanding of FDA’s observations. It should also demonstrate the establishment’s commitment to address the observations, including a commitment from senior leadership.

Responses should be well-organized and structured to:

• • • Address each observation separately
    • Note whether the establishment agree(s) or disagree(s), and why
    • Provide both corrective and preventive actions and timelines for completion
    • Provide both completed and planned actions and related timelines
    • Provide a method of verifying or monitoring the effectiveness of the actions
    • Submit documentation (e.g., training, Standard Operating Procedures (SOPs), corrective action plans, records, etc.)

Importantly, FDA also states that timely Form FDA 483 responses that include “appropriate corrective and preventive actions could impact FDA’s determination of the need for subsequent Agency action.” FDA encourages responses within 15 business days after the end of an inspection and, helpfully, notes that any responses received within that window “will be considered before further Agency action or decision.” Interested stakeholders may submit comments here on FDA’s Draft Guidance until August 5, 2024.

Please contact Julie Tibbets or any member of our Life Sciences Regulatory & Compliance practice with questions on FDA’s Draft Guidance or on responding to Form FDA 483s.

On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests (“LDTs”) under the Federal Food, Drug and Cosmetic Act (“FDCA”). As detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under the FDCA, and established a five-stage plan to phaseout the agency’s current general policy of “enforcement discretion” with respect to LDTs.

With the final rule’s July 5 effective date looming, two entities—a trade association and a laboratory—filed suit in federal court to overturn the final rule. In this Insight, we briefly summarize the legal theories advanced in the lawsuit and likely next steps.

Read the full alert here.

Rapid advancement in life sciences technologies has made keeping up with the legal implications more important than ever. Join the Berkeley Center for Law and Technology for the 2nd BCLT Advanced Life Sciences Institute, where you will learn from the experts about cutting-edge issues impacting your life sciences practice.

The programming will share key insights and best practices related to the rapid rise of AI in the life sciences and new trends for licensing, deals, and life sciences funding models. Expert will review key developments in the law (Section 112, obviousness-type double patenting), anti-counterfeiting and patient safety, and the ever-complex interplay of regulatory and IP exclusivities. Finally, don’t miss in-depth discussions on future pandemic preparedness and use of trade secrets v. patents for portfolio protection!

The Advanced Life Sciences Institute will be launched virtually through B-CLE on May 21 and 22.

Registration is free and available to all, and CLE will be offered.

On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including those manufactured by laboratories, are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Alongside the amendment, FDA issued its policy to phase in regulatory requirements for certain LDTs over the course of four years.

The FDA will host a webinar to provide an overview of the final rule on May 14, 2024. A link to register can be found here. The final rule is expected to have profound effects on many LDT developers. Goodwin’s Life Sciences Regulatory & Compliance Team are ready to work with clients to navigate the challenges that the final rule may pose. Our breakdown and analysis of the rule will be upcoming on Goodwin’s LDT Resource page.

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines (including those for rare diseases and children). On April 10, 2024, the European Parliament adopted its position on the European Commission’s legislative proposals with respect to (i) Regulation 2023/0131 that can be found here and (ii) Directive 2023/0132 that can be found here. For certain key areas covered in the proposed EU legislation, we have set out a brief summary of (i) the European Commission’s original proposals and (ii) the European Parliament’s proposed amendments. You can read more here.

Goodwin’s Rare Disease Initiative hosted its Annual Rare Disease Symposium in Boston on March 13, 2024. Participants were invited to join for an afternoon of engaging and inspirational conversations led by Julie Tibbets, Matt Wetzel, and Danielle Lauzon, in addition to networking with peers in the rare disease community. The program included speakers covering the patient, advocacy, policy, research, and CEO perspectives.

For more event highlights and key takeaways from our speakers, please visit the Goodwin Rare Disease Symposium 2024 page.

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read about the Q2 2024 updates here.

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory developed tests (“LDTs”) for administrative review.  Having swiftly moved to OIRA review in under 5-months from the publication of the proposed rule and under 3-months from the end of its comment period, the rule has undoubtedly been a top priority for the FDA.  Further, as of the date of this post, OIRA has scheduled four back-to-back meetings with interested stakeholders, all of which are to be held the week of March 18th.  All of this signals that the final rule remains on track for potential issuance in April 2024, the target date for final action on the rule as we previously discussed here.

Further, on March 14, 2024, the House Energy and Commerce Committee Chair and Subcommittee on Health Chair announced a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”  The hearing is scheduled for Thursday, March 21, 2024 at 10:00 AM ET.  Additional information on attending or viewing the hearing is available here.

Be sure to bookmark our dedicated LDT Resource Page to stay informed on the latest news and analyses on LDTs.