Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The U.S. Food and Drug Administration (FDA) has announced additional proposed changes to the Office of Regulatory Affairs (ORA) as part of its proposal to create a unified Human Foods Program (HFP), building on a proposal...more
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more
On November 12, President Biden announced his intention to nominate Dr. Robert Califf as Commissioner of the U.S. Food and Drug Administration (“FDA”). Dr. Califf, a cardiologist, previously served as FDA Commissioner in the...more
Trump Administration and Testing Companies Receiving Scrutiny - Throughout the COVID-19 pandemic, both viral and antibody testing have raised significant challenges for the government and private sector. As both federal...more
Yesterday, the U.S. Food and Drug Administration (FDA) posted on its website a conversation with FDA Deputy Commissioner for Food and Policy Response Frank Yiannas that addresses common questions concerning food availability...more
On February 26, 2020 the Food and Drug Administration’s (“FDA”) new commissioner, Dr. Stephen Hahn, acknowledged the growing consumer demand for CBD products. “People are using these [CBD] products,” Hahn said in his first...more
Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first...more
The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
Welcome - Welcome to the fourth 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
After being confirmed by the Senate in a 72-18 vote on December 12, 2019, the new Commissioner of the Food and Drug Administration (FDA) Dr. Stephen Hahn will be facing a number of critical issues on the immediate horizon...more
LEGISLATION, REGULATIONS & STANDARDS - Senate Confirms FDA Commissioner - The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in...more
When it comes to medical products — devices put in or substances put on our bodies — consumers may be ill-served by the federal regulators who are supposed to protect them from injury....more
The Senate Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration’s nominee to head the Food and Drug Administration (FDA), on December 3, 2019. Dr. Hahn faced a...more
Following the recent public hearing held by the Food and Drug Administration (FDA) regarding the safety and efficacy of cannabidiol (CBD), many in the food and beverage industry asked how long it will take for the agency to...more
Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the...more
As predicted by our colleagues earlier this month, outgoing Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) released a comprehensive press release setting forth actions for possible FDA regulation...more
Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the...more
The Trump Administration has lost yet another top health official: So, what happens now with key policies pushed by Scott Gottlieb, the departing federal Food and Drug Administration commissioner, to battle teen nicotine...more
On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, ?for whom this was ?a second stint at the FDA, intends to leave the agency in about a month to spend more time...more
During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more
Deflating the hype and exposing the risks of stem-cell treatments - Stem cells and regenerative medicine—a promising and complex field that has been a preoccupation of no less than popes, presidents, and top health policy...more