Federal judge enters consent decree against Specialty Compounding LLC
U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination.  The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.

The consent decree prohibits Specialty Compounding and its owners from manufacturing, holding or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, in addition to other requirements. More information

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible  para proporcionar  versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA

FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information

FDA launches drug shortages mobile app
FDA launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage. More information

• More information about drug shortages, drug shortages resolved, and drugs to be discontinued

• Information about blood and biologic shortages, resolved shortages, and discontinuations

FDA approves first therapy for high-risk neuroblastoma
FDA approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.

Neuroblastoma is a rare cancer that forms from immature nerve cells. It usually begins in the adrenal glands but may also develop in the abdomen, chest or in nerve tissue near the spine. Neuroblastoma typically occurs in children younger than five years of age. According to the National Cancer Institute, neuroblastoma occurs in approximately one out of 100,000 children and is slightly more common in boys. There are an estimated 650 new cases of neuroblastoma diagnosed in the United States each year. Patients with high-risk neuroblastoma have a 40 to 50 percent chance of long term survival despite aggressive therapy. More information

FDA approves CPR devices that may increase chance of surviving cardiac arrest
FDA approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.

The Centers for Disease Control and Prevention estimates that approximately 300,000 Americans experience an out-of-hospital cardiac arrest each year. CPR is an emergency procedure that can be life-saving for people in cardiac arrest. During this procedure, rescuers manually compress the patient’s chest and manually ventilate the lungs to keep blood oxygenated and circulating until the heart and breathing restart—or until the rescuers can apply advanced life-saving techniques, such as defibrillation. If provided immediately after cardiac arrest, this standard CPR procedure increases a patient’s chance of survival.  More information

FDA approves new antifungal drug Cresemba
FDA approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.

Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems. Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell membrane of a fungus. Cresemba is available in oral and intravenous formulations.
More information

FDA authorizes use of first device to treat patients with dialysis-related amyloidosis
FDA authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).

Dialysis-related amyloidosis is a chronic, progressive condition caused by the buildup in the body of a protein called beta 2-microglobulin. Dialysis-related amyloidosis is a complication of kidney failure. As beta 2-microglobulin builds up in the blood, deposits of the protein can form in the bones, joints and tendons causing painful and stiff joints, bone cysts that can lead to bone fractures, and torn tendons and ligaments. Beta 2-microglobulin deposits can also affect the digestive tract and organs, such as the heart and lungs. More information

FDA approves first biosimilar product Zarxio
FDA approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. More information

FDA expands approved use of Opdivo to treat lung cancer
FDA expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients, occurring when cancer forms in the cells of the lung.
More information

View FDA’s Comments on Current Draft Guidance page for a list of draft guidances on topics of interest for patients and caregivers.

FDA Advances Medical Product Innovation, by Margaret A. Hamburg, M.D., Commissioner FDA
On March 10, I had the pleasure of appearing with my colleague Dr. Francis Collins before the Senate Committee on Health, Education, Labor and Pensions to testify at a hearing on the subject of “Continuing America’s Leadership in Medical Innovation for Patients.” I thought the broader public health community would be interested in my oral testimony, and so I am sharing it here:

“Thank you, Mr. Chairman and Members of the Committee. I’m very pleased to be here today to discuss our shared goal of speeding innovative treatments to patients. FDA looks forward to working with you on this important effort.

As you have noted, this will be my last appearance before the Committee, as I am stepping down, but I want to thank you for your support over the years, and our constructive engagement with this committee to advance FDA’s public health mission.

To read the rest of this post, see FDA Voice Blog, March 17, 2015

FDA releases final guidance on reprocessing of reusable medical devices
FDA announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.

The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.

Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the complex design of some devices makes it harder to remove contaminants. More information

FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.

Other types of meetings listed may require prior registration and fees.

View FDA’s Calendar of Public Meetings page for a complete list of meetings and workshops.

Public Meeting on Breast Cancer Patient-Focused Drug Development
Date: April 2, 2015
Time: 1:00 pm to 5:00 pm
FDA is conducting a public meeting on Breast Cancer Patient-Focused Drug Development. FDA is interested in obtaining patient input on the impact of breast cancer on daily life and patients’ views on currently available therapies to treat the condition. More information

Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

Biosimilars: More Treatment Options Are on the Way
The medical marketplace is about to get bigger. The Food and Drug Administration (FDA) approved Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), and expects to approve other biosimilars in the future.

What are biosimilars? To understand that, says Leah Christl, Ph.D., Associate Director for Therapeutic Biologics, it helps to first understand what biological products (or biologics), are. Biologics are medicines that generally come from living organisms, which can include humans, animals and microorganisms such as yeast and bacteria. More information

Refrigerator Thermometers: Cold Facts about Food Safety
When it comes to protecting yourself and your family from foodborne illness, one of your most effective tools is the kitchen refrigerator. In fact, at room temperature, the numbers of bacteria that cause foodborne sickness can double every 20 minutes! Chilling foods to proper temperatures is one of the best ways to slow the growth of these bacteria.

To ensure that your refrigerator is doing its job, it’s important to keep its temperature at 40 °F or below; the freezer should be at 0 °F. Since few refrigerator controls show actual temperatures, using an inexpensive freestanding appliance thermometer will allow you to monitor the temperature and adjust the setting of the refrigerator and/or freezer if necessary. More information

FDA Investigates Listeria monocytogenes in Ice Cream Products from Blue Bell Creameries
According to the CDC and the Kansas Department of Health and Environment, five patients who were treated in a single hospital in Kansas were infected with one of four rare strains of Listeria monocytogenes. Three of these strains, which are highly similar, have also been found in products manufactured at the Blue Bell Creameries production facility in Brenham, Texas. Illness onset dates range from January 2014 to January 2015.

FDA was notified that these three strains and four other rare strains of Listeria monocytogenes were found in samples of Blue Bell Creameries single serving Chocolate Chip Country Cookie Sandwich and the Great Divide Bar ice cream products collected by the South Carolina Department of Health & Environmental Control during routine product sampling at a South Carolina distribution center, on February 12, 2015. These products are manufactured at Blue Bell Creameries’ Brenham facility.
More information

Sodium: Look at the Label
FDA is proposing to update the Nutrition Facts label for packaged foods. For more information, see Proposed Changes to the Nutrition Facts Label.

Over 75% of dietary sodium comes from eating packaged and restaurant foods. Most Americans eat too much sodium, and sodium has been linked to high blood pressure, which can increase your risk of heart disease, kidney disease, and stroke.

The Nutrition Facts Label is a handy tool you can use every day to get less sodium through smart dietary choices. FDA’s education materials show you how!

WATCH a video: “Don’t let your food take you by surprise. Read the label!”

También disponible en Español (Spanish)

Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics.
More information

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information

Animal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information

Animal and Veterinary Updates
Animal and veterinary updates provide information to keep your pets healthy and safe. More information

FDA Basics
Each month, different centers and offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

Educational Videos
FDA Food Safety and Modernization Act: An FDA Primer
The Rulemaking Process: An FDA Primer
What is Regulatory Science
Taking Acetaminophen Safely

Director’s Corner Podcasts
The Director’s Corner is a quarterly audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research and produced by CDER’s Office of Communications.

As 2015 begins, Dr. Woodcock discusses major events of 2014 and priorities for 2015.

• Download Podcast
• Download Transcript

healthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information

Tobacco Products Resources for You
Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics.
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FDA E-list
Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances.

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You may wish to sign up for other email updates from the FDA – see other email updates.