WASHINGTON DC (April 1, 2019) — The US Food and Drug Administration (USFDA) today posted warning letters to four companies who produce homeopathic drug-products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc of Asheville, NC.

WASHINGTON DC (March 29, 2019) — The US Food and Drug Administration (USDA) today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically-isolated syndrome.

WASHINGTON DC (March 28, 2019) — The US Food and Drug Administration today approved Cimzia (certolizumab pegol) injections for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.

WASHINGTON DC (March 27, 2019) — Today, the US Food and Drug Administration (FDA) announced important new steps to modernize breast-cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.

WASHINGTON DC (March 14, 2019) — The US Food and Drug Administration [FDA] today allowed marketing of a new device, ClearMate, intended to be used in an emergency-room setting to help treat patients suffering from carbon-monoxide poisoning. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s rate of breathing.

WASHINGTON DC (March 13, 2019) — Today, FDA announced publication of the draft guidance 

SILVER SPRING, MARYLAND (March 12, 2019) — Out of an abundance of caution, today Claire’s Stores Inc announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder, and Claire’s Contour Palette. We initiated this voluntary recall after testing by the US Food and Drug Administration indicated the possible presence of asbestos fibers in product-samples from one lot of each product.

WASHINGTON DC (March 8, 2019) —

Patient Affairs Staff (PAS)

Food and Drug Administration

US Department of Health and Human Services

 

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