jueves, 13 de abril de 2017

FDA Updates for Health Professionals

UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

ANNOUNCEMENTS

Spotlight on Science: Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers

Reliable biomarkers to assess treatment outcome are critical tools that would revitalize TB drug development. In particular, there is a need to identify better biomarkers that will more precisely predict risk of relapse. Such biomarkers may include lingering byproducts of the bacteria we have not yet been able to detect, or immunological biomarkers produced by patients with TB indicating whether or not they have been cured. More information

Helping Small Businesses Get Big Results

We may think of the pharmaceutical industry in terms of giant corporations, but the fact is that there are hundreds of small firms – with very few employees – that are developing many of the important drugs that we use every day. For many years, to help level the playing field, FDA has been assisting small pharmaceutical companies to maximize their opportunities for success. More information

FDA in India – Championing a Culture of Quality

One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of medical products exported from India to the U.S. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Considerations in Demonstrating Interchangeability With a Reference Product - Comment Period Extended

FDA has extended the comment period for the draft guidance for industry: “Considerations in Demonstrating Interchangeability With a Reference Product.” FDA originally published a notice with a 60-day comment period in the Federal Register of January 18, 2017. The Agency has received several requests for an extension of the comment period to allow sufficient time to develop a response to the notice. More information

Enhancing Patient Engagement Efforts Across the Food and Drug Administration Request for Comments

FDA is establishing a public docket to solicit input on ongoing efforts to enhance mechanisms for patient engagement at the Agency. Engaging with patients, their caregivers, and advocates has long been a priority of the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves new drug to treat multiple sclerosis

FDA approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional. More information

FDA approves new eczema drug Dupixent

FDA approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids. More information

FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

FDA approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy. More information

FDA approves first treatment for rare form of skin cancer

FDA granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed

PRODUCT SAFETY

MedWatch, The FDA Safety Information and Adverse Event Reporting Program

For important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here.

Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously

Medtronic notified customers worldwide of a voluntary field corrective action for all its Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator. More information

EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

Mylan N.V. announced an expanded voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets. This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). More information

Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

Merit Medical Systems Inc. recalled the Prelude Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the patient's bloodstream. This may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death. More information

LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

Envy Me is recalling LaBri’s Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The FDA analyzed samples of La Bri’s Body Health Atomic and found it to contain the undeclared ingredient sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. 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. More information

HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

Phillips recalled the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. More information

UPCOMING MEETINGS

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. Click on "more information" for details about each meeting.

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

Public Meeting on Patient-Focused Drug Development for Sarcopenia (Apr 6)

On April 6, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development (PFDD) for Sarcopenia. FDA is interested in obtaining patient perspectives on the on the impact of sarcopenia on daily life and patient views on treatment approaches. More information

Public Workshop: Emerging Tick-Borne Diseases and Blood Safety (Apr 6)

The purpose of the public workshop is to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions. The workshop has been planned in partnership with AABB; America’s Blood Centers; National Heart, Lung, and Blood Institute, National Institutes of Health (NIH); the U.S. Department of Defense; and the U.S. Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. More information

International Council for Harmonization Regional Public Consultation (Apr 24)

The FDA will be co-hosting a regional public consultation with Health Canada on April 24, 2017 to solicit public input prior to the next meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The topic areas relate to harmonization of various guidelines for the manufacture of pharmaceuticals. More information

Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Workshop (May 3)

The topics to be discussed will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2018 Regulatory Science Plan. More information

Public Meeting on Patient-Focused Drug Development for Autism (May 4)

On May 4, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development (PFDD) for Autism. FDA is interested in obtaining patient perspectives on the impact of autism on daily life and patient views on treatment approaches. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program

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

MedWatchLearn - Practice Reporting to FDA!

This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information

Cardiovascular and Endocrine Liaison Program

The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information

Medical Product Safety Network (Medsun)

Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. 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