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

"FDA opens door to feedback on ‘unclear’ national priority voucher pathway" was originally created and published by ...
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

Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises

Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory ...
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 ...
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Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...
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 ...
The National Law Review

FDA Releases Educational Materials on the NDIN Process

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Medscape

FDA's 510(k) System Should Be Scrapped, IOM Concludes

July 29, 2011 (Washington, DC) — The FDA's 510(k) process for clearing putatively moderate-risk devices has been criticized by some for being too lax and by others for obstructing innovation. Now, a ...