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The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...
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The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products.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New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific Knowledge

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...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 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 ...
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 ...
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FDA Issues New Draft Guidance Addressing Communications with Payors

On June 3, 2026, the Food and Drug Administration (“FDA” or “the Agency”) announced a new draft guidance, “Drug and Device Manufacturer ...

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 ...

Senators question tobacco firms on lobbying in wake of new FDA policy

A group of six Democratic senators sent letters to two tobacco companies on Thursday, asking for details on their dealings ...
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.