Becker's Hospital Review

FDA issues new guidance on compounded GLP-1 production

FDA issues guidance compounded GLP-1 production limits, restricting pharmacies to compound only during active shortages to ensure drug safety and ...
Healthcare Packaging

Navigating New FDA Expectations Under QMSR

On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) became effective and enforceable. After a two-year ...

FDA declines to issue specific guidance on health programs' foreign drug imports

A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
MobiHealthNews

Should mHealth companies want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
Marijuana Moment

New FDA Enforcement Memo Clears Way For Hemp CBD Product Coverage Under New Medicare Plan

The Food and Drug Administration (FDA) has issued guidance making clear that it does not intend to interfere with ...
STAT

Government watchdog urges FDA to finalize guidance for advisory committee conflicts of interest

The FDA has often failed to share information on how it determines whether advisory committee members have financial ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on patient preference information for devices

The US Food and Drug Administration (FDA) has finalized guidance on incorporating patient preference information (PPI) for assessing the benefit-risk profile of certain medical devices throughout the ...
BioSpace

FDA Reversals in Rare Disease Space Highlight Confusion Around External Controls

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...
MobiHealthNews

In-Depth: Anticipating FDA Regulation of Pharmaceutical Apps

Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...