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Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Troutman Pepper on

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

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The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Alston & Bird

Health Care Week in Review: House Passes Minibus, HHS Releases Public Inquiry on Private Equity in Health Care

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

Foley & Lardner LLP

FDA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know

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On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - December 2018 #2

BakerHostetler on

Food/Dietary Supplements - FDA Issues Avocado and Hot Pepper Sampling Reports – The Food & Drug Administration (FDA) has made available two reports related to the sampling of avocados and hot peppers for the presence of...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest - December 2018 #1

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Food/Dietary Supplements - FDA Investigates Multiple Foodborne Illness Outbreaks – The FDA and the CDC have launched a multistate investigation of a Salmonella Concord outbreak linked to certain tahini products. ...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

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This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

Foley & Lardner LLP

How Will Trump Change The FDA?

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President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or...more

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