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The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...
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FDA oncology draft guidance aims to reduce animal testing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 ...
RAPS

FDA updates manufacturer communications guidance to emphasize application to devices

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...
PharmExec

New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific Knowledge

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Adds New Submission Category in Human Factors Guidance Shake-Up

FDA revises 2022 human factors guidance with new risk-based categories, device modification examples, and 60-day ...

FDA Cyber Guidance Sets Priorities for Medical Device Companies

Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...
PharmTech

FDA Guidance for Accelerating Gene Therapies for Rare Diseases

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...
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 ...

FDA's new guidelines allow more e-cigarettes and nicotine pouches in the US

The FDA's new guidelines permit unauthorized e-cigarettes and nicotine pouches in the U.S., raising concerns among agency ...
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 ...