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Articles

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

May 6, 2024 | lexology.com | Jodi Scott |Lowell Zeta |Blake Wilson |Randy Prebula |Brooke Bumpers |Suzanne Friedman | +2 more

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the most notable changes between the proposed rule and Final Rule, including the grandfathering provision and inclusion of more carve-outs for categories of tests that will continue to receive enforcement discretion.
Advances in Precision Medicine, the Future of Diagnostics, and FDA Priorities in an Election year Hogan Lovells at JPM2024 | JD Supra

Feb 22, 2024 | jdsupra.com | Blake Wilson |Lowell Zeta

Precision medicine seeks to provide an individualized therapy for each patient – with the right treatment at the right time – by adjusting for the nuances within an individual’s genetic profile, health records, and lifestyle. These cutting edge drug development programs are increasingly offering new opportunities for life-saving therapies. Yet, with these game-changing technologies come novel issues and new regulatory challenges, as FDA’s regulatory standards evolve behind industry innovation.
JPM2024: What to expect from FDA in an election year | JD Supra

Jan 5, 2024 | jdsupra.com | Lowell Zeta

“Precision” or “personalized” medicine seeks to provide a bespoke therapy for the right patient – with the right treatment at the right time – by adjusting for the nuances within an individual’s genetic profile, health records, and lifestyle. These drugs can produce unprecedented clinical effect with low toxicity compared to other therapies by relying on molecular structures that are not present in all patients.
JPM2024: What to expect from FDA in an election year

Jan 4, 2024 | lexology.com | Lowell Zeta

The annual J.P. Morgan Healthcare Conference (JPM) provides a unique opportunity to make connections among life sciences and health care emerging companies, pharma/biotech companies, investors, and advisors. Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients.
FDA webinar on speedy LDT rule finalization leaves key questions unanswered | JD Supra

Dec 14, 2023 | jdsupra.com | Randy Prebula |Blake Wilson |Lowell Zeta

By April 2024, FDA plans to finalize its October 2023 proposed rule seeking to assert regulatory authority over LDTs, according to the Department of Health and Human Services (HHS) Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions. While the timeline is ambitious, and these dates are often missed and may be revised given the volume of comments logged in the docket, FDA has expressed urgency in moving forward.
FDA webinar on speedy LDT rule finalization leaves key questions unanswered

Dec 14, 2023 | lexology.com | Randy Prebula |Lowell Zeta |Blake Wilson

The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as drafted) is intended to clarify the agency’s authority to regulate LDTs as medical devices, despite receiving more than 6,000 comments that were mostly critical of the proposal.
FDA's Lab-Developed Test Rule Faces High Hurdles

Oct 10, 2023 | law360.com | Blake Wilson |Lowell Zeta |Randy Prebula

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FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028 | JD Supra

Oct 5, 2023 | jdsupra.com | Randy Prebula |Blake Wilson |Lowell Zeta

Since the 1990’s, FDA has maintained the position that LDTs are medical devices over which the agency exercises enforcement discretion, except in some limited cases (e.g., when certain higher risk factors are present).
FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028

Oct 5, 2023 | lexology.com | Blake Wilson |Lowell Zeta |Randy Prebula

In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where the manufacturer of the IVD is a laboratory, are medical devices as defined by the Federal Food, Drug, and Cosmetic Act (FDCA) and will be regulated by the agency as such.
Life science companies should work with FDA to shape AI regulation

Jul 25, 2023 | lexology.com | Lowell Zeta |Blake Wilson

Artificial intelligence tools present groundbreaking opportunities in the development of drugs and biologics and in manufacturing these medicinal products, with the potential for streamlining drug development and improving health outcomes through process optimization, advanced process controls and enhanced surveillance.