Fierce Pharma

FDA citizen petition calls on agency to tighten up CRL disclosure practices

The FDA’s new practice of releasing redacted complete response letters (CRLs) in the name of “radical transparency” is ...
Fierce Biotech

FDA celebrates progress to end animal testing but experts warn there’s still a long way to go

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission ...
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 ...
MobiHealthNews

How the FDA process is biased against new technology

And FDA explains that they don’t have any extra. Congress has been underfunding FDA for decades, and the agency only stays afloat now by virtue of user fees the industry pays to get submissions ...
RAPS

New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
AOL

FDA wants to use AI to speed up drug approval process

FDA officials want more AI in the review process. The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in ...
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 ...
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 ...