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.
Fierce Pharma1h
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 ...
The American Journal of Managed Care50m
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 ...
Why the FDA wants to restrict kratom-related products
The FDA announced that it is urging the Drug Enforcement Agency to "classify 7-OH as a Schedule 1 substance, placing it on a ...
Sunscreen boss slams FDA recall for putting him "out of business"
The CEO said that the FDA's regulation of sunscreen, particularly for organic products, was "impossible" to meet.
FDA commissioner predicts ‘record’ drug approvals this year
FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...
Phoenix New Times1h
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.