Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.
Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun.
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.
The U.S. Food and Drug Administration and the government of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and Federal Commission for the Protection from Sanitary Risks (COFEPRIS) signed a statement of intent forming a partnership to promote the safety of fresh and minimally processed agricultural products.
Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the […]
The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.
The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.
The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act.
The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
As previously reported, on July 1, 2014, biological samples were found in the cold storage area of U.S. Food and Drug Administration laboratories on the National Institutes of Health campus. The FDA has since acquired additional information from the federal investigative agencies regarding inventories of the materials.
Triceutical, Inc., of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations, known as Current Good Manufacturing Practice (cGMP) requirements.
The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.
A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.
On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally […]
Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a […]
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk is a motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and […]
Hematology and Oncology Center (HOC) PLLC of Somerset, Kentucky has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC’s former office manager, Natarajan Murugesan, also pleaded guilty to assisting with these activities, which are violations of the Federal Food, Drug, and Cosmetic Act. The charges were […]
Today, three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.