News

FDA Outlines Process To Speed Up Rare Disease Therapy Approvals

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...
PharmExec

Lilly’s Orforglipron Considered ‘Prime Candidate’ for New FDA Fast Track Approval Program: Report

Eli Lilly's Orforglipron may become the first drug fast-tracked under the FDA's new program, promising quicker access for ...
Food Dive

FDA takes first step toward closing GRAS ingredient ‘loophole’

The agency is proposing a requirement that companies submit data when self-affirming an additive is safe for consumption.

US FDA proposes new process to accelerate approval of drugs for rare diseases

The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare ...
PharmiWeb

FDA Accelerated Approval What’s Changing and Why It Matters for Rare Diseases

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access to ...
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...
Waste Advantage Magazine

NEXTLOOPP Receives U.S. FDA Approval for 100% Food-Grade Recycled Polypropylene

NEXTLOOPP, the multi-participant global project led by Nextek Ltd, today announced that the U.S. Food and Drug Administration ...