New FDA rules for TV drug ads: Simpler language and no distractions
FDA’s requirement for truthful, balanced risk and benefit information applies to drugmakers, leaving a loophole for both ...
Newsweek2h
FDA's New Rules Require TV Drug Ads to Be Clearer, More Direct
The U.S. Food and Drug Administration (FDA) now requires TV and radio drug ads to be clearer and more direct. The new ...
Reuters19h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
Nov 13 (Reuters) - The U.S. Food and Drug Administration approved PTC Therapeutics ... The drugmaker will also get the FDA's ...
medtechdive1h
FDA breakthrough device decisions rebound after recent declines
The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
FDA adds new warning to weight loss drugs
The FDA has added a new warning to drugs including Ozempic and Wegovy, cautioning that patients taking the drugs may be at a ...
STAT2d
FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’
The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...
STAT20h
FDA is still struggling with a lack of inspectors, but doesn’t have a plan, watchdog finds
A key reason positions haven't been filled is that they require travel that ranges from 25% to 75% of the time.
Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
BioPharma Dive3d
FDA lifts pause on Novavax flu vaccine trials
The Food and Drug Administration has cleared Novavax to move forward with ... 3 trial of its combination shot after the ...
US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines, the company said on Monday.
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 ...
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Unapproved Drugs in the US and FDA Enforcement
In 2011, the FDA issued a Revised Guidance to clarify that, from September 19, 2011; any unapproved drug introduced to the market will initiate immediate prosecution action without previous warning.