FDA warns Mexicos Broncolin about multiple violations in its production and marketing of Harbacil antiseptic hand sanitizer.
FDA says Sunstar Americas has expanded the expiration dates in its Paroex recall that is due to microbial contamination.
FDA says the Cook Medical recall of two Flexor introducers is Class 1.
FDA approves Ridgebacks Ebanga human monoclonal antibody for treating Zaire ebolavirus.
FDA strengthens the REMS for transmucosal immediate-release fentanyl products to help ensure proper prescribing to opioid-tolerant patients.
FDA issues a final guidance on the content of REMS documents submitted electronically in structured product labeling.
FDA issues a guidance on review times for certain complete response letters during the pandemic.
FDA publishes a question-and-answer guidance on the consumer antiseptic rub final rule.