How some food additives bypass the FDA review process

Today, the vast majority of new food additives, most of them industrially produced, make it to market via the GRAS pathway through a loophole. The post How some food additives bypass the FDA review

The FDA is psyched on psychedelics. Which ones will be studied and why?

After an executive order, the FDA announced it would prioritize the study of some psychedelic drugs for therapeutic use. Which did they choose and why?
Indianapolis Business Journal

Complex process leads to a new drug’s identity

The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal analysis and regulatory compliance.
Fierce Biotech

FDA celebrates progress to end animal testing but experts warn there’s still a long way to go

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission accomplished for its first-year goals. | The FDA says it has hit the one-year goals of its roadmap for ending animal testing.
Healio

FDA issues complete response letter for trenibotulinumtoxinE

The FDA issued a complete response letter regarding AbbVie’s biologics license application for trenibotulinumtoxinE, a fast-acting botulinum toxin, requesting more information about its manufacturing processes,
BioSpaceOpinion

Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.