The U.S. Food and Drug Administration today expanded the approved use of Abraxane (paclitaxel protein-bound particles for injectable suspension) to treat patients with late-stage (metastatic) pancreatic cancer.
Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws. The U.S. Food and Drug Administration entered into a consent decree of permanent injunction on Aug. 26, 2013 which enjoined the drug maker and distributor for repeated […]
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series […]
The U.S. Food and Drug Administration is reminding health care providers about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. Health care providers should not administer any NuVision Pharmacy sterile products to patients because the products’ sterility is not assured.
La Administración de Alimentos y Medicamentos aprobó hoy Tivicay (dolutegravir), un nuevo fármaco para tratar la infección de VIH-1.
The U.S. Food and Drug Administration has awarded a $5.6 million contract to Harvard University’s Wyss Institute for Biologically Inspired Engineering to apply its breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness.
The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX. There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.
The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 […]
The U.S. Food and Drug Administration today published a new regulation defining the term “gluten-free” for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.
The U.S. Food and Drug Administration is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits. Nova Diabetes Care announced a recall on July 26, 2013.
In order to implement the bipartisan Food Safety Modernization Act (FSMA) signed by President Obama, the U.S. Food and Drug Administration today issued two proposed rules aimed at helping to ensure that imported food meets the same safety standards as food produced in the United States.
Today, the U.S. Food and Drug Administration is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids, methasterone, a controlled substance and dimethazine. These ingredients are […]
The U.S. Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
The U.S. Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. The […]
Today, the U.S. Food and Drug Administration issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes.
The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s […]
The U.S. Food and Drug Administration today proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.
The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.