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Food and Drug Administration (FDA) Regulatory Reform Pharmacies

Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

Bradley Arant Boult Cummings LLP

How Will the Cannabis World Look When Marijuana Is Rescheduled?

A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Arnall Golden Gregory LLP

In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule

Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

Holland & Knight LLP on

On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

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