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Food and Drug Administration--Press Releases

Press releases from FDA


FDA approves new psoriasis drug

The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.

FDA approves drug to treat Duchenne muscular dystrophy

The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Emflaza is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system.

Federal judge approves consent decree with California dietary supplement dist...

A California dietary supplement distributor has been ordered by a federal court to stop selling its products, which were found to contain unsafe ingredients including 1, 3-dimethylamylamine (DMAA).

FDA permits marketing of first newborn screening system for detection of four...

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

FDA confirms elevated levels of belladonna in certain homeopathic teething pr...

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.

FDA approves Trulance for Chronic Idiopathic Constipation

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

Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology C...

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.

Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guid...

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.

FDA and EPA issue final fish consumption advice

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.?)

FDA approves first drug for spinal muscular atrophy

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.

FDA permits marketing of new tissue expander for women undergoing breast reco...

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.

FDA expands indication for continuous glucose monitoring system, first to rep...

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.

FDA grants accelerated approval to new treatment for advanced ovarian cancer

The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.