Brian Burgess on Food and Drug Administration (FDA)

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product”...more

9/25/2024 / Eli Lilly , Food and Drug Administration (FDA) , Intellectual Property Litigation , Pharmaceutical Industry , PHSA , Prescription Drugs

Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more

6/3/2024 / Administrative Procedure Act , Clinical Laboratories , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more

4/26/2021 / Exclusivity , FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , New Legislation , Pharmaceutical Industry , Prescription Drugs

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more

1/7/2021 / Biosimilars , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Life Sciences , New Amendments , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs...more

4/10/2020 / CARES Act , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Regulatory Reform

Brian Burgess

Goodwin

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

Brian Burgess

Goodwin

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

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