Reed Abrahamson

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more

5/12/2025 / Clinical Trials , Data Integrity , Enforcement Actions , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

4/8/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Statutory Interpretation , Vacated

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

Why Do Clinical Trials? Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more

11/12/2020 / Biologics , Clinical Trials , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Research and Development

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