Dream Body Weight Loss Issues Voluntary Nationwide Recall of Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg Due to Undeclared Sibutramine
Dream Body Weight Loss is voluntarily recalling all lots of Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules to the consumer level. The Dream Body Extreme 800mg Gold, Dream Body 450mg and Dream Body Advanced 400mg have been found to contain sibutramine after FDA sampling and testing.
Dream Body Weight Loss has not received any reports of adverse events related to this recall to date. More information
Michael’s® Naturopathic Programs Issues Allergy Alert on Undeclared Milk and Soy in The Dietary Supplement Cholesterol Metabolism Factors™ Michael’s® Naturopathic Programs of San Antonio Texas is recalling certain lots of the dietary supplement Cholesterol Metabolism Factors™, because it may contain undeclared milk (in the form of calcium caseinate) and soy. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products. Cholesterol Metabolism Factors™was distributed nationwide in the US through retail stores and online (internet) ordering. 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 importante sobre seguridad de los medicamentos 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 inglés y la de 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
Drug Shortages Voluntarily Reported 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 y prevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendo problemas 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 riesgos involucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escasez tendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa para restablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información
FDA approves first absorbable stent for coronary artery disease The FDA approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.
“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. More information
FDA approves implantable device that changes the shape of the cornea to correct near vision The FDA approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision. More information
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection: First regimen to treat all six major HCV genotypes The FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.
“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.
FDA Advisory Committee Members and ‘Appearance Issues’, by Michael Ortwerth, Ph.D, FDA’s Director of the Advisory Committee Oversight and Management Staff
FDA relies on its advisory committees as a source of independent scientific and technical expertise and advice on challenging public health issues. Most advisory committee members are appointed as “special government employees” (SGEs). Like regular government employees, these committee members are subject to Federal conflict of interest laws and regulations.
A lack of understanding about our selection and evaluation process has, at times, resulted in confusion and misunderstandings by the public. We’ve been working to bring greater transparency to how the financial interests of committee members are evaluated.
What has not been previously addressed in guidance is something called “appearance issues.” Sometimes FDA advisory committee members who do not have interests and relationships that are financial conflicts of interest nevertheless have interests and relationships that may create the appearance that they lack impartiality. To read the rest of this post, see FDA Voice June 29, 2016
Leveraging the Power of Collaboration – FDA’s New Oncology Center of Excellence, by Richard Pazdur, M.D., FDA’s Acting Director, Oncology Center of Excellence I am honored to be selected by Commissioner Califf as the acting director of FDA’s new Oncology Center of Excellence (OCE) in support of the Vice President’s National Cancer Moonshot Initiative.
This new center will be a place where the combined skills of regulatory scientists and reviewers with oncology clinical expertise in drugs, biologics, and devices will come together to support an integrated approach to the advancement of cancer treatment.
Such a collaborative approach – the sharing of ideas, information and best practices – closely fits my own vision for oncology at the FDA. To read the rest of this post, see FDA Voice June 29, 2016
FDA Celebrates the 40th Anniversary of the Medical Device Amendments, by Jeffrey Shuren, M.D., J.D., FDA’s Director of the Center for Devices and Radiological Health In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”
Unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.
Although Congress had first given FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, the focus was on fraudulent products. Efforts to extend FDA’s oversight on medical devices failed in 1962 and again in 1970. To read the rest of this post, see FDA Voice June 22, 2016
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.
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.
Whole Body Cryotherapy (WBC): A “Cool” Trend that Lacks Evidence, Poses Risks Your rheumatoid arthritis is flaring up? A trainer at your local gym suggests a safe and easy way to treat it: a three-minute session in a freezing tank, called whole body cryotherapy (WBC). He says not only will WBC help you put an end to rheumatoid arthritis pain better than an ice bath or pack, but also promises that a couple sessions will help with depression and weight loss! Not so fast.
The problem is, this so-called “treatment” hasn’t been proven to do any of these things.
And despite claims by many spas and wellness centers to the contrary, the FDA does not have evidence that WBC effectively treats diseases or conditions like Alzheimer’s, fibromyalgia, migraines, rheumatoid arthritis, multiple sclerosis, stress, anxiety or chronic pain. More information
FDA requests additional information to address data gaps for consumer hand sanitizers The FDA issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.
Antiseptic rubs are products that are intended to be used by consumers when soap and water are not available, and are left on and not rinsed off with water. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands. More information
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
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 and Publicaciones en Español del
Animal and Veterinary Updates Animal and veterinary updates provide information to keep your pets healthy and safe. More information
How to Report a Pet Food Complaint You can report complaints about a pet food product electronically through the Safety Reporting Portal or you can call your state’s FDA Consumer Complaint Coordinators. Please provide as much information as possible in your complaint, such as exact name of product, type of container, lot number, UPC codes, how the food was stored, and purchase date and exact location where purchased. If possible, please save the original packaging until the pet food has been consumed. The packaging contains IMPORTANT information often needed to identify the variety of pet food, the manufacturing plant, and the production date. 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.
Access the latest Health Information available from our Federal partners.
Public Education Campaigns We are investing in a number of public education campaigns, such as Fresh Empire and 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
Information about Expanded Access Expanded access, sometimes called “compassionate use,” is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. More information
Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more. Information for Patients
Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more. Information for Physicians
Patient Network Webinars Through our webinars and presentations, the Office of Health and Constituent Affairs brings information to you on many topics related to patient engagement, medical product (Drugs, Biologics, Devices) approval and medical product safety updates. 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
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
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Dale Donohoe and Kim Kurowski were named the Santa Clarita Valley's top volunteers of the year at the 2024 SCV Man and Woman of the Year dinner celebration held Friday, May 3 at the Hyatt Regency Valencia. The event also honored all of the 17 men and 17 woman nominated for the award.
The Santa Clarita Valley Media Collaborative invites the public as well as local creatives, media industry professionals, students, parents, teachers and others to celebrate the next generation of media makers participating in the inaugural NextGen MediaMakers Festival on Saturday, May 18 from 2-5 p.m. at the Canyon Country Community Center.
Dale Donohoe and Kim Kurowski were named the Santa Clarita Valley's top volunteers of the year at the 2024 SCV Man and Woman of the Year dinner celebration held Friday, May 3 at the Hyatt Regency Valencia. The event also honored all of the 17 men and 17 woman nominated for the award.
The regular meeting of the Saugus Union School District Governing Board will take place Tuesday, May 7, with closed session beginning at 5:30 p.m., followed immediately by public session at 6:30 p.m.
The city of Santa Clarita Arts Commission is holding its regular meeting in City Hall's Council Chambers Thursday, May 9 at 6 p.m. The meeting will be held at Santa Clarita City Hall, 23920 Valencia Blvd., Valencia, CA 91355.
Experience the Butterfly Encounter at Gilchrist Farm open now on weekends thorugh Sunday, June 18. Walk through a tent of beautiful flowers hosting live butterflies that fly freely throughout the tent.
The Santa Clarita Community College District Board of Trustees will hold a business meeting Wednesday, May 8, beginning at 5 p.m. The board will first meet in closed session at 4:15 p.m.
The Santa Clarita Valley Media Collaborative invites the public as well as local creatives, media industry professionals, students, parents, teachers and others to celebrate the next generation of media makers participating in the inaugural NextGen MediaMakers Festival on Saturday, May 18 from 2-5 p.m. at the Canyon Country Community Center.
Explore Vasquez Rocks during the magical twilight and early evening full moon hours. These fun, collaborative, interpretive hikes are led by trained staff and volunteers and will highlight the park's natural and human history.
Astrotourism is top of mind for travelers making special trips for experiences in the sky, and with the recent “take-your-breath-away” total solar eclipse, thousands of cruisers onboard Emerald Princess and Discovery Princess off the coast of Mexico caught a glimpse of the total darkness event.
The Santa Clarita City Council will hold a study session on Tuesday, May 7 at 5 p.m. The council will meet at City Hall, Carl Boyer Room, 23920 Valencia Blvd., First Floor, Santa Clarita, CA 91355.
Garbage inspectors will soon be paying a visit to neighborshoods throughout the Santa Clarita Valley to inspect recycling bins to insure residents are following the recycling rules in the SCV.
College of the Canyons competed at the 3C2A State Singles & Doubles Championships for a second straight year, with the doubles duo of Sydney Tamondong and Estrella Segura establishing program history by advancing to the round of 16 at the Ojai Athletic Club.
College of the Canyons men's basketball head coach Howard Fisher's Cougar Basketball Camp returns in 2024 with three sessions open to boys and girls ages 8 to 14.
The Friends of Santa Clarita Public Library is hosting a “Spring Bag Sale” event at the Valencia, Canyon Country and Newhall branches of the Santa Clarita Public Library, during normal operating hours from Saturday, May 4 to Sunday, May 12.
A former public school teacher who launched a racist and anti-immigrant tirade against a Santa Clarita street vendor is being sued by a Latino civil rights group for civil assault and violating California civil rights laws.
The Village of Pine Mountain Club has hosted wine festivals since 2003. You can taste exciting wines from the world’s top wine-growing regions, with dozens of premier wineries to choose from on Saturday, July 6, 1-4 p.m. at Wine in the Pines.
The American Cancer Society Relay For Life of Santa Clarita Valley will be held Saturday, May 4, 9 a.m.-9 p.m. at Central Park, with the theme “May The Cure Be With You,” a Disney/Star Wars celebration.
CEDAR RAPIDS, Iowa -- The Master's University men's volleyball team won their opening match of the 2024 NAIA National Championship with a 3-set win over the No. 9-seed Mount Mercy (IA) Mustangs.
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