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Public Health Service Act Draft Guidance

Hogan Lovells

FDA explains when medical device makers must notify of an interruption in manufacturing

Hogan Lovells on

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA’s New Draft Guidance Regarding Biosimilarity and Interchangeability

On November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the submission of biologics license applications (BLAs) and labeling for...more

Patterson Belknap Webb & Tyler LLP

FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...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On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”).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

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Goodwin

The (suf)Fix is In: FDA Opens the Floor for Comments on Biologic Naming Guidance

Goodwin on

On June 2, 2016, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name...more

Goodwin

“Deemed to be a License” Provision Poses Potential Issues for Biological Products

Goodwin on

The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”)....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FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule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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