Impact of the US election on medical device regulations
While Trump and Robert F Kennedy Jr have named the FDA as a target of particular interest for deregulation efforts, much of ...
In RFK Jr., drugmakers face an antagonist with regulatory power
Anxious and bewildered, some drugmakers are reaching out to their lobbyists about how Robert Kennedy’s pending nomination ...
policymed.com20h
Updates from FDA’s Office of Prescription Drug Promotion: Standards for Direct-to-Consumer Advertising
In a recent presentation at the 25th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, Catherine Gray, ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
The Lancet1d
Building robust, proportionate, and timely approaches to regulation and evaluation of digital mental health technologies
Demand for mental health services exceeds available resources globally, and access to diagnosis and evidence-based treatment ...
RFK Jr. vow to purge FDA sets up collision with Big Pharma
Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food and tobacco products ...
In Robert F. Kennedy, drugmakers face antagonist with regulatory power
Pharmaceutical industry representatives in Washington are scrambling to measure the damage Robert F. Kennedy Jr. might inflict on the FDA.
Med Device Online15d
AI-Enabled Medical Device Manufacturers: Are You Prepared for Evolving FDA Oversight?
As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...
JD Supra3d
How the US Election May Affect the FDA Regulation of Life Sciences Products – Key Areas to Watch
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, ...
Here’s how Robert F. Kennedy Jr. has promised to remake the nation’s top health agencies
WASHINGTON (AP) — Robert F. Kennedy Jr., an anti-vaccine activist and environmentalist, for years gained a loyal and fierce ...
Becker's Hospital Review11d
The future of FDA's medical device unit: 4 notes
Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...