The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis. This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults. Depression is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime.
La Administración de Alimentos y Drogas de los Estados Unidos (FDA) aprobó hoy los implantes de seno rellenos de gel de silicona fabricados por Sientra Inc. para aumentar el tamaño del seno (aumentación) en las mujeres por lo menos 22 años de edad y para reconstruir el tejido de los senos (reconstrucción) en las mujeres […]
Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. As a condition of approval, Sientra is required to conduct post-approval studies that will assess […]
The Food and Drug Administration today approved GINTUIT, the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. GINTUIT is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
Tobacco use is the leading cause of preventable death in our nation. And until we dramatically decrease the access and appeal of tobacco products to youth, it will remain one of America’s most pressing health problems. Today’s ground-breaking report by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s […]
The U.S. Food and Drug Administration today approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.
The U.S. Food and Drug Administration today issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the use of AeroShot […]
Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.
FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved today by the U.S. Food and Drug Administration. FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains.
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.
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration (FDA). These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev […]
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 […]
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. […]