FDA opens door to feedback on ‘unclear’ national priority voucher pathway

The US Food and Drug Administration (FDA) will convene a public hearing intended to obtain feedback on its Commissioner's ...
The American Journal of Managed Care

Higher-Dose Semaglutide Approved Under New FDA Accelerated Review Process

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight ...
BioSpace

9 Months In, FDA’s New Priority Voucher Program Still Clouded With Uncertainty

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic ...
BioSpace

FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...
Becker's ASC

FDA contemplates changing approval process for software used as a medical device — 4 insights

The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
MobiHealthNews

How the FDA process is biased against new technology

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...
Becker's Hospital Review

New FDA office will update drug approval process

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...
WLKY

FDA official plans to change vaccine approval process

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...