US FDA updates guidance to speed up drug development

June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up ...
Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
Regulatory Affairs Professionals Society

HHS and FDA propose clinical trial reforms to expedite drug development

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory classifications.
Food

FDA’s 2025 Food Agenda: What industry must know

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...
CIO

Why the FDA’s new real-world evidence guidance ends the era of structured-data-only submissions

The FDA's new rules mean you can no longer just submit basic health data codes, since the most critical patient details are ...
The Washington Post

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...
MedCity News

The FDA’s Bayesian Guidance Could Quietly Reshape Clinical Trial Design

New FDA guidance on the use of Bayesian statistics signals a broader shift in accommodating more flexible clinical trial ...
JD Supra

FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements

On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information ...
CNBC

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...