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The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...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 finalizes two guidances for industry on establishing bioequivalence

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...
JD Supra

FDA Updates 8-Year-Old Payor Communications Guidance

Last week, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a new draft guidance on drug and device ...
Health AffairsOpinion

Refining FDA’s Plausible Mechanism Framework, Part 2: Manufacturing Challenges, Product Scope, And Post-Approval Considerations

This is part two of a two-part article offering proposals to improve the FDA’s draft guidance to implement a new approval ...
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 ...
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The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products.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 ...
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FDA releases draft guidance to accelerate gene therapy development

FDA's draft guidance shows gene therapy developers how to use prior knowledge and platform data to accelerate regulatory ...

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 ...
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 ...