FDA’s New Guidance Plan to Face Trump's Transparency Efforts
A revamped plan to streamline the FDA’s guidance practices stands to be tested as President-elect Donald Trump looks to ...
Medpage Today on MSN6d
Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance
There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared ...
JD Supra2d
Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics
In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, ...
JD Supra13d
FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission ...
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
dermatologyadvisor10d
FDA Updates Meaning of ‘Healthy’ on Food Labels
The US FDA wants to redefine the meaning of healthy food, changing the way food companies can claim their products are indeed ...
IBN Coverage: Clene (NASDAQ: CLNN) Receives FDA Roadmap on Potential Accelerated Pathway for CNM-Au8(R)
This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the ...
MyChesCo on MSN5d
FDA Approves First Generic Liraglutide Injection, Ushering in a New Era for Type 2 Diabetes Treatment
The fight against type 2 diabetes just reached a groundbreaking milestone. Last week, the U.S. Food and Drug Administration ...
centerforbiosimilars8d
The Top 5 Most-Read Policy Articles of 2024
The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar ...