Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

Healium Announces FDA Registration of Healium Clinical as a Class II 510(k)-Exempt Biofeedback Medical Device

For decades, biofeedback has relied on graphs and monitors. With this new FDA registration, a new generation of immersive ...

DEA's New Marijuana Registration Questions Redefining the Cannabis Industry - And MMJ International Already Has the Answer

"As Federal Courts Review Cannabis Policy and CMS Expands Cannabinoid Access, MMJ's FDA-and-DEA-Compliant Pharmaceutical Track Record Emerges as a Potential Competitive Advantage" stated Duane Boise, ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: Malaysia’s NPRA starts recognition procedure pilot for drugs approved by FDA and EMA

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.
Pharmabiz

Healium announces US FDA registration of Healium Clinical as a Class II 510(k)-exempt biofeedback medical device

Healium, a non-pharmacological digital health company, announced the US FDA registration of Healium Clinical as a Class II 510(k)-exempt biofeedback medical device. The US FDA registration accelerates ...