Category: FDA

November 6, 2020 Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration's drug compounding program, and we are committed to protecting patients. While compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, these drugs have not been reviewed by the FDA for safety, effectiveness, or quality. The FDA through its oversight of compounded drugs strives to help improve the...

With high sensitivity and specificity,ii Ortho's SARS-CoV-2 antigen test offers exceptional utility for mass-scale testing where appropriate.

A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.

The device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction.

The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end-organ oxygenation. The 510(k) clearance is to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours.

Nerivio now has clearance for use in acute treatment of migraine with or without aura in patients 18 years of age or older, without limitation to episodic migraine. The clearance is supported by results from two clinical studies with chronic migraine patients.