Axios on MSN

FDA issues industry-friendly gene therapy guidance

The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...
BioProcess International

FDA releases draft guidance to accelerate gene therapy development

FDA's draft guidance shows gene therapy developers how to use prior knowledge and platform data to accelerate regulatory ...
Ophthalmology Times

FDA guidance to help accelerate cell and gene therapies

The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...
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FDA oncology draft guidance aims to reduce animal testing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 ...
BioSpaceOpinion

Opinion: The next FDA commissioner must be a champion for gene therapies

The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene ...
Regulatory Affairs Professionals Society

FDA to exempt five more unclassified devices from premarket notification

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...
MedCity NewsOpinion

Former FDA Officials: There’s Opportunity to Rebuild the Agency — But Not the Way It Was

Rick Pazdur, formerly the FDA’s top oncology official, said the FDA is at a critical juncture that could determine the ...
Medical Design & Outsourcing

FDA rules, regulations and resources for artificial intelligence in medical devices

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
Health AffairsOpinion

Why FDA’s Plausible Mechanism Framework Matters For Ultra-Rare Disease Policy

Ultra-rare diseases often lack patient populations large enough to support randomized controlled trials. The question is not ...
STAT

Blood pressure tech floods the market after FDA relaxes wearables oversight

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...
STAT

FDA announces sweeping changes to oversight of wearables, AI-enabled devices

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.