Alistair McIntyre on Food and Drug Administration (FDA)

FDA Accuses Third Party Testing Labs of Falsifying Data

The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

5/30/2025 / China , Data Integrity , Enforcement Actions , False Claims Act (FCA) , Food and Drug Administration (FDA) , Investigations , Manufacturers , Medical Devices , Regulatory Oversight , Third-Party

CDRH Announces Pilot Program to Improve Recall Communication

On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls. The CDRH intends for the pilot...more

12/2/2024 / CDRH , Food and Drug Administration (FDA) , Pilot Programs , Product Recalls

Test Anxiety: FDA Issues Warning Letters to Test Laboratories

The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more

9/19/2024 / Clinical Laboratory Testing , FDA Warning Letters , Food and Drug Administration (FDA) , Quality Assurance Programs , Standard Operating Procedures

Science Group Sues FDA Over New Laboratory-Developed Test Rule

On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more

9/9/2024 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Popular

FDA Issues Final Rule on Laboratory-Developed Tests

On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more

5/2/2024 / Enforcement , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices

Shutdown will Impact FDA

The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be...more

9/29/2023 / Administrative Agencies , Appropriation , Federal Funding , Food & Drug Regulations , Food and Drug Administration (FDA) , Furloughs , Government Shutdown , Premarket Approval Applications , Regulatory Agencies

FDA Approves Generic Fluorescein Injection

On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more

9/29/2023 / FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Healthcare , Life Sciences , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

Supreme Court Issues Stay in Mifepristone Case, Preserving Status Quo for Now

On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The...more

5/2/2023 / Abortion , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Reproductive Healthcare Issues

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

4/3/2023 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Final Guidance , Food and Drug Administration (FDA) , Healthcare , Marketing Authorization Application , Medical Devices , Pharmaceutical Industry , Public Health Emergency

Alistair McIntyre

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