First IPF Biomarker Clears Initial FDA Step Toward Qualification

The Prognostic Lung Fibrosis Consortium (PROLIFIC), a collaborative consortium advancing biomarker tools for pulmonary ...
Morningstar

FDA Accepts Integral Molecular's Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool

PHILADELPHIA, Feb. 5, 2025 /PRNewswire/ -- Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their Membrane Proteome Array™ (MPA) ...
PharmTech

FAQ: FDA’s Shifts in Pharma Regulation and Strategy in 2025

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...

Understanding ANDA: Process for Approving Generic Drugs by the FDA

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.
Business Insider

PathAI's AIM-MASH AI Assist¹ Becomes First AI-Powered Tool to Receive FDA Qualification for MASH Clinical Trials

BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- PathAI , a global leader in AI-powered pathology, today announced that the U.S. Food and Drug Administration (FDA) has qualified AIM-MASH AI Assist through ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
News Medical

C-Path receives FDA’s clinical outcome assessment qualification for SMDDS

Critical Path Institute's (C-Path) Patient-Reported Outcome (PRO) Consortium announces its first clinical outcome assessment (COA) qualification from the US Food and Drug Administration (FDA) for the ...