The U.S. Food and Drug Administration has reached a $1 million civil money penalty settlement with Globus Medical Inc., of Audubon, Pa., for the distribution of unapproved medical devices.

The first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2012.

A federal court has granted the U.S. Food and Drug Administration a permanent injunction preventing Daniel L. Allgyer and his Rainbow Acres Farm from distributing raw milk and raw milk products in final package form for human consumption across state lines.

The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages.

Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.

On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.

The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.

Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.

The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. (MB)

The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.