Food and Drug Administration--Press Releases

FDA issues draft guidance on biosimilar product development

Thu, 09 Feb 2012 12:22:00 -0500

The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

FDA and industry reach agreement in principle on medical device user fees

Wed, 01 Feb 2012 09:48:00 -0500

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

Tue, 31 Jan 2012 17:29:00 -0500

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

FDA approves Kalydeco to treat rare form of cystic fibrosis

Tue, 31 Jan 2012 10:59:00 -0500

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

FDA takes action against New York cheese manufacturer

Tue, 31 Jan 2012 10:13:00 -0500

The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.

FDA approves new treatment for most common type of skin cancer

Mon, 30 Jan 2012 10:58:00 -0500

Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

FDA approves Inlyta to treat patients with a type of advanced kidney cancer

Fri, 27 Jan 2012 12:09:00 -0500

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Department of Justice files Consent Decree of Permanent injunction against Ranbaxy

Wed, 25 Jan 2012 16:59:00 -0500

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities

Maine company holds cold smoked salmon product after FDA order

Tue, 24 Jan 2012 18:04:00 -0500

A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

Fri, 20 Jan 2012 15:21:00 -0500

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

FDA approves Voraxaze to treat patients with toxic methotrexate levels

Tue, 17 Jan 2012 16:58:00 -0500

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

FDA completes work on three drug user fee programs

Fri, 13 Jan 2012 12:37:00 -0500

The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

FDA expands use of endovascular graft to treat aortic tears

Fri, 13 Jan 2012 15:59:00 -0500

The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (MB)

FDA to protect important class of antimicrobial drugs for treating human illness

Wed, 04 Jan 2012 12:05:00 -0500

The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.

FDA expands use of Prevnar 13 vaccine for people ages 50 and older

Fri, 30 Dec 2011 14:22:00 -0500

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

FDA to approve shared system REMS for TIRF products

Thu, 29 Dec 2011 13:38:00 -0500

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.

FDA: Chicago-area sandwich manufacturer agrees to stop production

Thu, 22 Dec 2011 15:08:00 -0500

The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.

FDA expands use of HIV drug Isentress to children and adolescents

Wed, 21 Dec 2011 12:52:00 -0500

Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.

FDA: Do not use ShoulderFlex Massager

Wed, 21 Dec 2011 11:57:00 -0500

The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.

FDA collaboration to monitor rare eye condition associated with cataract surgery

Tue, 20 Dec 2011 10:18:00 -0500

The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.

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