Jonathan Trinh on Food and Drug Administration (FDA)

FDA’s LDT Final Rule Rejected by Federal District Court in Texas

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for...more

4/4/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Judicial Review , Medical Devices , Regulatory Authority , Statutory Interpretation , Vacated

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

3/13/2025 / Drug Compounding , Enforcement Actions , Food and Drug Administration (FDA) , Pharmaceutical Industry , Popular , Preliminary Injunctions , Prescription Drugs , Regulatory Oversight , Regulatory Requirements

FDA Announced Removal of Tirzepatide from the Drug Shortage List

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more

1/3/2025 / Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Popular , Prescription Drugs , Supply Chain , Supply Shortages

FDA Issues Multiple Guidances Supporting Clinical Trial Innovation

In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow...more

9/27/2024 / Biotechnology , Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Research , Pharmaceutical Industry

FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices

The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more

9/4/2024 / Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

8/1/2024 / Data-Sharing , Drug Testing , Electronic Medical Records , Food and Drug Administration (FDA) , Health Care Providers , Medical Research , Pharmaceutical Industry , Prescription Drugs

FDA Publishes Machine Learning Transparency Guiding Principles for Medical Devices

Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more

7/10/2024 / Artificial Intelligence , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Medical Software , Transparency

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

7/3/2024 / Clinical Laboratories , Compliance , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Manufacturers , Medical Devices

Jonathan Trinh

Wilson Sonsini Goodrich & Rosati

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