FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risksFDA has 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. The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP. More information
Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved
FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. More information
Recall: Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux - Potential for Test Result Error
bioMérieux recallied the Etest PIP/TAZO/CON-4 PTC 256 because the test results from the affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria. This error may result in inappropriate treatment of a patient’s infection and could cause serious patient health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.More information
Recall: Insulet Corporation OmniPod Insulin Management System - Needle May Fail to Deliver Insulin
The OmnniPod Insulin Management System is an insulin pump used to deliver insulin to people with diabetes. The insulin pump is a small adhesive “Pod” that sticks directly on the body. Insulin is delivered through a small port holding a tube that is inserted into the skin. The Pod's needle mechanism may fail or delay in inserting the needle. If the needle mechanism fails or there is a delay, the needle will not be inserted in the patient's skin and insulin delivery will not begin. The interruption of insulin delivery may lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or even death. More information
Recall: Various Products Distributed for Weight Loss by Bee Extremely Amazed - Undeclared Drug IngredientsBee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. More information
Recall: Apexxx by Nuway Distributors - Undeclared Drug IngredientNuway Distributors llc is voluntarily recalling all lots of Apexxx tablets to the consumer level. FDA analysis found Apexxx to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. 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
No shortages or discontinuations to report from the past two weeks.
More information about drug shortages, drug shortages resolved, and drugs to be discontinued
Information about blood and biologic shortages, resolved shortages, and discontinuations
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
No new medical product approvals to report from the past two weeks.
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.
Opportunities to Comment Closing January 2016
Opportunities to Comment Closing February 2016
Opportunities to Comment Closing March 2015
2015: Another Strong Year for Patients in Need of New Drug Therapies, John Jenkins, M.D., Director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research
Happy New Year! Looking back at 2015, I’m pleased to report another strong year for FDA approvals of novel new drugs, which offer many patients new treatment options for serious and life-threatening conditions. In 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel new therapies – significantly more than the average of 28 we have approved during the previous nine years of this decade. But far more important than quantity is quality – and the valuable new roles many of these drugs can serve in advancing medical care and the health of patients. During this past year, we approved many new drugs to treat various forms of cancer, including four to treat multiple myeloma, and others to treat lung, skin, breast, brain, colorectal, and other cancers. We also approved new drugs to treat heart failure, high cholesterol, cystic fibrosis, and irritable bowel syndrome, as well as the first approved reversal agent for a commonly-used blood thinner. And, for the second consecutive year, we approved more drugs to treat rare diseases than any previous year in our history.
To read the rest of this post, see the FDA Voice Blog, January 4, 2016.
FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation, by Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs
As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting Commissioner. FDA has broad responsibilities – indeed, we are tasked with overseeing products that account for about 20 cents of the consumer dollar — so we work on a wide range of topics in any given year. In this and two additional blog posts over the coming days I’ll cover some of our key accomplishments in 2015. Each blog will examine a different area of FDA’s work. This first post will focus on medical product innovation – our role in making safe, effective and innovative products available to patients who need them. Scientific advances and unprecedented innovation in the sectors we regulate make it an exciting time to work at and lead FDA. To protect and promote the public health our regulatory decision-making must be nimble and current, adapted to the forward march of science.
To read the rest of this post, see FDA Voice Blog, December 29, 2015.
FDA Invites Patient Organizations to Take a Place at the Podium, by Theresa M. Mullin, Ph.D., Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research
Sometimes, the most valuable thing we can do as regulators at FDA is simply to listen. I’m reminded of that each time we hold a public meeting as part of the Patient-Focused Drug Development (PFDD) program. We began PFDD to more systematically obtain the patient perspective on certain diseases and their treatments. The effort is part of an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Each public meeting is focused on a specific disease area. Our commitment is to gain perspectives on at least 20 disease areas by the end of FY 2016. And having already held 17 meetings to hear from patients with diseases as varied as breast cancer, fibromyalgia and sickle cell disease, we are well on our way. What have we learned so far?
To read the rest of this post, see FDA Voice Blog, December 28, 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.
Public Meeting: Food and Drug Administration Safety and Innovation Act 907 Public Meeting - Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup DataDate: February 29, 2016
The purpose of the public meeting is to report on FDA’s progress implementing the Action Plan, to discuss how stakeholders have been affected by these changes, and to solicit feedback and recommendations for further implementation from interested parties and stakeholders. Federal Register Notice
Public Meeting: Advancing the Development of Pediatric Therapeutics (ADEPT) - Successes and Challenges of Performing Long-Term Pediatric Safety StudiesDate: April13-14, 2016
The purpose of this two day meeting is for FDA to have an open discussion with experts in the field regarding the length of pediatric safety studies. Day 1 will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 will focus on suggestions for the future on study design and implementation for long-term safety studies in children. Viewpoints of patient representatives of children with long-term conditions and industry will be included. 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.
Who's in Clinical Trials?
Have you ever wondered if someone like you participated in the clinical trials for a new drug? If you have, you’re not alone.
That’s why FDA is making demographic information from clinical trials, such as the inclusion of women and minority groups, more easily available to consumers through its online Drug Trials Snapshots database. This section of the FDA website is written in an easy-to-read format so you can see who took part in research studies for new drugs by sex, race, and age.
“Now patients can go to just one section of the FDA website and immediately find answers. For example, how many women, Asians, and blacks participated in research studies that supported the approval of a new drug,” says Naomi Lowy, M.D., a doctor at FDA.
Snapshots also help people understand if there are any differences in the benefits or side effects of a new drug between men and women, and among patients of different races and ages. “Patients can use this information as one resource to discuss the use of a drug with their doctor and to evaluate its benefits and side effects,” says Lowy.
To read the rest of this article, see For Consumers.
Get Set for a Healthy Winter Season
Although contagious viruses are active year-round, we’re most vulnerable to them in fall and winter. That’s because, in large part, we spend more time indoors with other people when the weather gets cold. Fortunately, you can fight back with several FDA-approved medicines and vaccines. Most respiratory bugs come and go within a few days, with no lasting effects. But some cause serious health problems. People who use tobacco or who are exposed to secondhand smoke are more prone to respiratory illnesses and more severe complications than nonsmokers. 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
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