FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.

Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers.

We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues. Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.

We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues. Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.

Today, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency issued final advice regarding fish consumption. This advice is geared toward helping women who are pregnant or may become pregnant – as well as breastfeeding mothers and parents of young children – make informed choices when it comes to fish that are healthy and safe to eat. (This advice refers to fish and shellfish collectively as “fish.”)

The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.

The U.S. Food and Drug Administration today allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander.

The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.