CSP Daily News

FDA advisory committee to review Zyn nicotine pouches’ modified risk tobacco product claims

The Food and Drug Administration will hold a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting on Jan.
Fierce Healthcare

FDA advisory committee to roll up sleeves on generative AI this week

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. The meeting will be ...

Those with positive experiences or conflicts of interest dominate FDA drug advisory meetings

U.S. Food and Drug Administration (FDA) advisory committees play a key role in evaluating the efficacy and safety of new ...
MedPage Today on MSNOpinion

The FDA Commissioner Is Missing the Point of Advisory Committees

FDA advisory committee meetings are scheduled for drugs, devices, or tobacco products when there is conflicting evidence or a ...

Throw Away Your Old Pots NOW — FDA Issues Chilling Lead Warning Over Dozens of Imported Cooking Pans

The FDA has urgently warned Americans to discard 19 types of imported cookware after tests showed they may leach dangerous ...
FiercePharma

FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval for its liver disease drug Ocaliva has come up short. Intercept on ...
FierceBiotech

Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner

Capricor Therapeutics saw its shares fall 13% by the end of trading Monday as its investigational cell therapy deramiocel for DMD was revealed as the first drug expected to face an FDA advisory ...