 | ||
|
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
|
Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades legales para abordar yprevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendoproblemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgosinvolucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escaseztendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa pararestablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información
|
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System - P120005/S031 Aproved for MarketingThe Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System (Pediatric CGM System) is an externally-worn glucose sensor that continuously measures and displays glucose values. In addition to reporting glucose values every 5 minutes, the system reports trending information in real-time for up to seven days (the life of each sensor). This supplement updates the software in the pediatric version that calculates the glucose values from the sensor signal. The updated software has improved the accuracy of the system, primarily for glucose values less than or equal to 70 mg/dL. This allowed for the removal of performance warnings from the device receiver and labeling. More information
FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms
FDA has approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors. More information
FDA approves Radiesse Injectable Implant - P050052/S049
The Radiesse Injectable Implant (Radiesse) is a white, sterile, injectable implant. Radiesse is a dermal filler that can increase volume in the back of the hand to reduce the appearance of veins and tendons due to volume loss. Radiesse consists of synthetic calcium hydroxylapatite particles suspended in a gel containing sterile water, glycerin and sodium carboxymethylcellulose. More information |
FDA allows marketing of new device to help the blind process visual signals via their tongues
FDA has allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues. The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary. More information
FDA has allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues. The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary. More information
FDA approves new antiplatelet drug used during heart procedure
FDA has approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle. According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.More information
FDA has approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle. According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.
View FDA's Comments on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.
|
Protecting Consumers from Trans Fat, by Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition
FDA is taking a step today to remove artificial trans fat from the food supply. This action will save many thousands of lives. PHOs or partially hydrogenated oils have been used as ingredients since the 1950s to improve the shelf-life of processed foods. FDA has issued a final determination that PHOs, the primary source of industrially-produced trans fat in processed foods, are not “Generally Recognized as Safe” or GRAS. This means that PHOs may no longer be added to food after June 18, 2018, unless they are otherwise approved by FDA. In this case, it has become clear that what’s good for extending shelf-life is not equally good for extending human life.
To read the rest of this post, see FDA Voice Blog, June 16, 2015.
|
 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.
MDUFA Public Meeting
Date: July 13, 2015 FDA will hold a public meeting to gather initial input on reauthorization of the Medical Device User Fee program, as required by section 738A of the Federal Food, Drug, and Cosmetic Act. If you wish to attend this meeting or view the webcast, you must register by close of business on July 2, 2015. More information
View FDA's Calendar of Public Meetings page for a complete list of meetings and workshops.
|
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.
|
Disposable Wipes
Disposable wipes are made for baby care, hand washing, feminine and other personal cleansing, removing makeup, and applying products such as deodorants and sunless tanners, among other uses. Many wipes, but not all, are regulated as cosmetics. While these products are convenient, consumers need to know what’s in them, how to use them safely, and how to report problems: |
More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español
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 andPublicaciones en Español del
Animal and Veterinary Updates
Animal and veterinary updates provide information to keep your pets healthy and safe. More information |
Kids and Tobacco Use: Some Surprising Findings
The number of kids smoking cigarettes is down—but the number using other tobacco products is way up. That’s the word from the 2014 National Youth Tobacco Survey (NYTS), co-conducted by the Centers for Disease Control and Prevention (CDC) and FDA. “This is the only nationally representative survey of middle and high school students that focuses exclusively on tobacco use,” says Benjamin J. Apelberg, Ph.D., branch chief of epidemiology at FDA’s Center for Tobacco Products. Survey results provided a national snapshot of what tobacco products today’s middle and high school youth are using, as well as emerging trends over time. More information
Public Health Education
Tobacco products are harmful, yet widely used, consumer products that are responsible for severe health problems in both users and non-users. These health problems include cancer, lung disease, and heart disease, which often lead to death.
|
Public Education Campaigns
We are investing in a number of public education campaigns, such as The Real Cost, to help educate the public – especially youth – about the dangers of regulated tobacco products. Rooted in science, these efforts are directly linked to our authority to regulate the marketing and sales of tobacco products. More information
We are investing in a number of public education campaigns, such as The Real Cost, to help educate the public – especially youth – about the dangers of regulated tobacco products. Rooted in science, these efforts are directly linked to our authority to regulate the marketing and sales of tobacco products. More information
Youth and Tobacco
We are working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use. More information
We are working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use. 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 PrimerThe 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. |
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 /más información
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.
You may wish to sign up for other email updates from the FDA - see other email updates.
|
Patient Network - Bring Your Voice to FDA
An interactive tool for educating patients, patient advocates, and consumers on how their medications - both prescription and over-the-counter - and medical devices move from the realm of idea to the realm of the marketplace. More information |
.png)
No hay comentarios:
Publicar un comentario