STAT

Opinion: Bringing order to the ‘wild frontier’ of microbiome medicine

When it comes to #microbiome medicine, @US_FDA and @NIH need to create a solid, science-based regulatory framework to help realize the promise of living drugs.

I never thought I’d someday write the sentence, “I really enjoyed that FDA meeting.” But here I am doing just that.

The topic of the meeting — regulatory implications of an emerging class of medicines to promote health by modulating the teeming microbial ecosystems that live inside each of us — may not sound like much fun, but for those of us in the field it was both enjoyable and enlightening.

, co-hosted by the National Institutes of Health, drew a packed house, filling a large conference room and two overflow rooms with clinicians, patient advocates, and industry representatives.

You’re reading a preview, subscribe to read more.

More from STAT

STAT2 min read
STAT+: Brain Biopsies On ‘Vulnerable’ Patients At Mount Sinai Set Off Alarm Bells At FDA, Documents Show
A STAT Investigation: Brain biopsies on "vulnerable" patients at Mount Sinai set off alarm bells at FDA, documents show.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About A Senate Probe Into Novo Pricing, A New UTI Antibiotic, And More
The U.S. Senate health committee is investigating the prices Novo Nordisk charges for its blockbuster medications Ozempic and Wegovy.
STAT2 min read
STAT+: Pharmalittle: We’re Reading About CVS And Humira Biosimilars, Schumer’s Broken Insulin Promise, And More
New prescriptions for biosimilar versions of Humira, one of the best-selling drugs in the U.S., surged to 36% from just 5% during the first week of April.

Related