News

Food Dive1d

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.

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 ...
Fierce Biotech9d

UPDATE: Analyst questions impact of FDA's rare disease pathway proposal

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

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 ...
PharmiWeb3d

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 ...
BioPharma Dive9d

FDA outlines new review pathway for drugs treating ultra-rare diseases

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...
Hosted on MSN1mon

New medications coming soon: Here’s what’s been FDA approved in 2025 so far

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
Scripps News on MSN4d

FDA approves first human clinical trials for gene-edited pig kidney transplants

Scientists reached a major milestone in animal-to-human transplant research as the FDA approved the first human clinical ...
Medscape15y

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...