Regulatory Affairs Professionals Society

FDA oncology draft guidance aims to reduce animal testing

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...
Regulatory Affairs Professionals Society

FDA, industry discuss need for flexibility in early phase clinical development of cell therapy products

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...
MobiHealthNews

How the FDA process is biased against new technology

Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea. Indeed, let’s say there’s nothing else like it. To bring the first tongue ...
Fierce Biotech

Makary’s FDA reforms ‘continue to move forward’ despite leadership turmoil

As the FDA adjusts to life without Marty Makary, M.D., Fierce has learned that the numerous policy reforms he put in motion ...
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 ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
Hosted on MSN

FDA wants to use AI to speed up drug approval 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 even more automation amid thousands of federal worker ...
Health on MSN

An experimental weight loss drug could outperform Ozempic. Here’s what makes it different.

Fact checked by Nick Blackmer Retatrutide is an investigational weight loss drug that targets three hormones, compared to the ...

Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of ...
Just The News

New FDA leadership brings cultural shift and mentality shakeup

As the FDA''s deputy commissioner for food, Diamantas, a former food and drug attorney, led the agency's Human Foods Program ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...