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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
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
On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”).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
On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more
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
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
On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars.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
On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more
On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more