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Pharmaceutical Industry › Proposed Regulation › Biologics

Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

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Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Mintz - Health Care Viewpoints on

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

Goodwin

FDA’s New Draft Biologic Naming Guidance

Goodwin on

On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current...more

Foley & Lardner LLP

CMS Proposed Rule Reduces Drug Payments & Requires Implementation of Value-Based Purchasing Tools

Foley & Lardner LLP on

Proposed Rule - Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether...more

Mintz - Health Care Viewpoints

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

Mintz - Health Care Viewpoints on

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

McDermott Will & Emery

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

McDermott Will & Emery on

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

Foley & Lardner LLP

FDA’s Proposed Naming Convention for Biologics

Foley & Lardner LLP on

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

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