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Press releases from FDA
Updated: 2 years 5 days ago

Federal judge enters consent decree against Downing Labs

Mon, 01/11/2016 - 14:20
On Friday, Jan. 8, U.S. District Judge Sam A. Lindsay entered a consent decree of permanent injunction between the United States and Downing Labs LLC, of Dallas, Texas, and the company’s co-owners, Ashley Michelle Downing and Christopher Van Downing, and pharmacist-in-charge, Roger E. Mansfield.
Categories: In the News

FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers

Thu, 01/07/2016 - 11:40
The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.
Categories: In the News

US Marshals seize dietary supplements containing kratom

Wed, 01/06/2016 - 14:06
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.
Categories: In the News

The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation

Wed, 01/06/2016 - 08:36
The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).
Categories: In the News

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

Mon, 01/04/2016 - 08:44
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
Categories: In the News

FDA approves Zurampic to treat high blood uric acid levels associated with gout

Tue, 12/22/2015 - 16:51
The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.
Categories: In the News

FDA approves new orphan drug to treat pulmonary arterial hypertension

Tue, 12/22/2015 - 08:44
On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
Categories: In the News

FDA updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the U.S. blood supply

Mon, 12/21/2015 - 10:55
Today the U.S. Food and Drug Administration issued a final guidance outlining updated donor deferral recommendations that appropriately protect the U.S. blood supply by reducing the risk of transmitting human immunodeficiency virus (HIV) infection.
Categories: In the News

FDA permits marketing of fecal continence restoration system

Fri, 12/18/2015 - 09:13
The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
Categories: In the News

FDA proposes tanning bed age restrictions and other important safety measures

Fri, 12/18/2015 - 07:57
Today, the U.S. Food and Drug Administration announced important proposed steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning.
Categories: In the News

FDA approves wearable defibrillator for children at risk for sudden cardiac arrest

Thu, 12/17/2015 - 12:37
The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
Categories: In the News

FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes

Wed, 12/16/2015 - 15:26
The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Categories: In the News

FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery

Tue, 12/15/2015 - 14:14
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.
Categories: In the News

FDA takes action against Vermont dairy farm for illegally administering drugs to cattle

Tue, 12/15/2015 - 11:59
Today, the U.S. Department of Justice entered a consent decree of permanent injunction in the District of Vermont against the Correia Family Limited Partnership, doing business as Wynsum Holsteins, a dairy farm located in West Addison, Vermont, and its partners, Anthony Correia, Barbara Correia and Stephen Correia. The decree accompanies a complaint filed at the request of the U.S. Food and Drug Administration.
Categories: In the News

FDA approves new oral therapy to treat ALK-positive lung cancer

Fri, 12/11/2015 - 12:03
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
Categories: In the News

FDA approves first emergency treatment for overdose of certain types of chemotherapy

Fri, 12/11/2015 - 11:05
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
Categories: In the News

FDA allows marketing of cooling cap to reduce hair loss during chemotherapy

Tue, 12/08/2015 - 15:07
Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
Categories: In the News

FDA approves first recombinant von Willebrand factor to treat bleeding episodes

Tue, 12/08/2015 - 13:44
The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD.
Categories: In the News

FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

Tue, 12/08/2015 - 09:43
Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
Categories: In the News

FDA clears military traumatic wound dressing for use in the civilian population

Mon, 12/07/2015 - 15:49
Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication for use from use by the military only to use in adults and adolescents in the general population.
Categories: In the News