Supplement industry groups oppose National Institutes of Health’s proposal to move Office of Dietary Supplements to be part ...

Brands that use AI to polish product performance visuals or that include synthetic figures in ads risk turning off shoppers ...

Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in ...

Efficacy among previously treated HR+/HER2- breast cancer patients looked in line with Merck/Kelun’s sac-TMT, but an analyst ...

NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it ...

Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in ...

A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start ...

Former FDA officials at a NAMSA-hosted panel urged medical device manufacturers to maintain inspection readiness under the ...

The UK wants to change the way medtech companies interact with its medical regulator via a more transparent process and ...

NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” ...

Staff who left the FDA in recent months are being enticed to come back by efforts to return to historical operations, but ...

Saudi Arabia’s NADR rewrites rules for rare disease drug research with 20-day designation reviews and flexible evidence ...