News

FDA Issues Risk Warning for Aldi Churro Recall in 13 States
Camerican International, Inc. issued a voluntary recall of Casa Mamita Churro Bites due to a potential undeclared allergen.
The American Journal of Managed Care19m
FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Fierce Pharma50m
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
MedPage Today18h
Want to Judge Data on FDA-Cleared AI Systems for Alzheimer's? Good Luck With That
Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...
Botanic Tonics Applauds FDA Action on Synthetic 7-Hydroxymitragynine Products
Botanic Tonics has consistently advocated for regulations that distinguish between authentic kratom leaf products and ...
Phoenix New Times30m
FDA recommends ban of potent 7-OH kratom variant
The synthetic variant is legal and has opioid-like effects. One official called it “a recipe for a public safety disaster.” ...
FDA seeks controlled substance status for potent synthetic opioid sold in gas stations
The FDA recommended classifying 7-OH as a Schedule I controlled substance due to its opioid-like effects and its use in unregulated products.
Trump drove firing of FDA official
The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.