Health ❯Regulatory Affairs

FDA

Food Recalls Vaccine Authorization Drug Regulations Product Safety Drug Shortages Product Monitoring Drug Warnings Drug Approval Medical Device Approval Drug Approval Process Drug Safety

Sarepta Shares Plummet on FDA Review of Elevidys Following Third Patient Death

Regulators are weighing a voluntary pause of Elevidys shipments with a black-box warning after reports of a third fatal liver failure.

FDA Warns of Rare Severe Itching After Stopping Common Allergy Medications

Systane Eye Drops Recalled Over Potential Fungal Contamination

Dynacare Baby Powder Recall Expands to 42,000 Bottles Over Asbestos Contamination

FDA Recalls Duloxetine Over Cancer-Causing Chemical Concerns

16,500 Cans of Baby Formula Recalled Due to High Vitamin D Levels