ANNOUNCEMENTS

Califf, FDA top officials call for sweeping review of agency opioids policies

In response to the opioid abuse epidemic, Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. For more information, see the Press Release and Dr. Califf'sVoice Blog.

Building a Modern Generic Drug Review Process

Recent hearings on Capitol Hill highlighted an issue of growing importance for patients and for public health: access to quality, affordable medicines, in particular generic drugs. FDA’s generic drug program promotes access to quality affordable medicines by reviewing Abbreviated New Drug Applications (ANDAs), the pathway that allows generic drugs to come to market. The generic drug sector has been enormously successful, growing from about 40 percent of drugs dispensed about 20 years ago to 88 percent today. And the cost savings have been enormous – approximately $1.68 trillion from 2005 to 2014 alone. More information

Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs

FDA is working with drug makers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective — with an eye toward avoiding drug shortages. When manufacturing problems arise in drug manufacturing facilities, drug shortages may follow. In fact, 65 percent of all drug shortages are caused by manufacturing and quality issues. This underscores the need for a safe and reliable drug supply chain. More information

Building a case for medical device interoperability: FDA’s Call to Action

From blood pressure to brain scans, today’s health care allows for the rapid transfer and use of information between and among different medical devices. This concept—called interoperability—is less about basic communication and more about the smart and safe interaction among medical devices and information systems. More information

Using Social Media to Teach Consumers About Heart Health

February is American Heart Month. Heart disease remains a significant problem in the United States – it’s the leading cause of death, disproportionately affecting minorities. In particular, minorities have higher rates of hypertension, diabetes, and smoking, which are risk factors that can cause heart disease. This month, we’ll be working with the Centers for Disease Control and Prevention and the National Institutes of Health to help raise awareness. More information

FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality

FDA is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget – an eight percent increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the Vice President. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Applying Human Factors and Usability Engineering to Medical Devices Guidance

FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments. More information

List of Highest Priority Devices for Human Factors Review - Draft Guidance

FDA is issuing this guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions (i.e., for PMA, 510(k)). FDA believes these device types have clear potential for serious harm resulting from use error, and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first drug to show survival benefit in liposarcoma

FDA approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.” More information

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

FDA approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. The safety and efficacy of Zepatier with or without ribavirin was evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received Zepatier with or without ribavirin once daily for 12 or 16 weeks. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response or SVR), suggesting a participant’s infection had been cured. More information

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

PRODUCT SAFETY

Need Safety Information?

For more 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 emailsubscribe here.

SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings

Arkray is recalling the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mg/dL, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome in a timely manner and fail to treat elevated blood glucose levels. There have been no reports of illness or injury from the use of the SPOTCHEM II Test Strips, but this issue may cause serious injury or death.More information

MOVES Ventilator System by Thornhill Research: Class I Recall - Battery Problem

Thornhill Research Inc. is recalling the MOVES ventilator system because excess glue on the battery connectors may prevent the battery from powering the device after the battery is stored. This issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death. The MOVES Ventilator System is a portable emergency transport ventilator that provides breathing support for adults patients. The primary users of this device are medical doctors. More information

Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient

Lucy's Weight Loss System of Arlington, TX, is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750MG per capsule) to the consumer level. Pink Bikini and Shorts on the Beach may contain an undeclared active pharmaceutical ingredient. More information

Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning

FDA is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. FDA laboratory analysis of the product found elevated lead levels. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems. More information

Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning

FDA is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning. FDA laboratory analysis identified mercury in the product. Exposure to mercury can cause serious health problems, such as kidney and nervous system damage. Mercury can also interfere with brain development in children. Signs and symptoms of mercury poisoning include, irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, and numbness and tingling in hands, feet or around the mouth. 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.

Cellular, Tissue, and Gene Therapies Advisory Committee (Feb 16)

The committee will hear updates of the updates of research programs in the Tumor Vaccines and Biotechnology Branch and the Cellular and Tissue Therapy Branch of the Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, FDA. More information

Risk Communication Advisory Committee (Feb 16-17)

The Committee will discuss recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee (Feb 18)

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.More information

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (Feb 19)

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. More information

Arthritis Foundation & Food and Drug Administration Accelerating OA Clinical Trials Workshop (Feb 23-25)

The goal of this workshop is to provide a forum for open discussion between leading osteoarthritis experts in academia, industry, the non-profit sector, and government, with the ultimate goal of identifying next steps in improving osteoarthritis clinical trials and accelerating the development of safe and effective treatments for osteoarthritis. More information

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee (Feb 25-26)

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for "TOPAS Treatment for Fecal Incontinence," by ASTORA Women's Health, LLC. The device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. More information

Next Generation Sequencing-Based Oncology Panels Workshop (Feb 25)

FDA is announcing the following public workshop entitled “Next Generation Sequencing-Based Oncology Panels.” The purpose of this workshop is to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for evaluation of NGS-based oncology panels in cancer patient management. More information

Patient and Medical Professional Perspectives on the Return of Genetic Test Results Workshop (Mar 2)

FDA is announcing the following public workshop titled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” The purpose of this workshop is to understand patient and provider perspectives on receiving genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, how those results should be returned, and what information is needed to understand the results so that they may effectively aid in medical decision making. More information

Vaccines and Related Biological Products Advisory Committee (Mar 4)

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season. More information

Primary Sclerosing Cholangitis (PSC) Workshop with the FDA, AASLD, ACG, AGA and NASPGHAN (Mar 3-4)

This workshop will provide a forum for discussion of issues related to PSC by academic specialists and researchers, industry, the FDA, representatives from the European Medical Authority (EMA) and other international regulatory agencies, and the patient community. The workshop will provide presentations and discussions on what is known about PSC, the definition, natural history and current therapeutic interventions for PSC, also presentations and additional discussions of potential trial designs and endpoints, including surrogate endpoints for clinical trials intended to support marketing applications for drugs to treat PSC in both adults and children. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee (Mar 15-16)

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. More information

NEW DATE - Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy Workshop (Mar 18)

The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. More information

2016 DILI Conference XVI: How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials? (Mar 23-24)

The purpose of this scientific workshop is to discuss ways in which to measure, evaluate and act upon liver injury and dysfunction caused by drugs in clinical trials. The primary audience includes leading academic experts, interested pharmaceutical companies, regulatory agencies, patient advocacy groups, non-profit organizations, scientists, clinicians from regulatory, academic, industrial and other healthcare sectors, scientists involved in drug development in those same industries, pharmacokineticists (clinical, preclinical, and toxicokinetics) who are involved in qualification of safety biomarkers or directly impacted by the qualification of safety biomarkers for drug development. More information

Psychopharmacologic Drugs Advisory Committee (Mar 29)

The committee will discuss the specific risk-benefit profile for new drug application (NDA) 207318, NUPLAZID (pimavanserin) 17 milligram (mg) immediate-release, film-coated oral tablets, submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of psychosis associated with Parkinson's disease. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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 endruginfo@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

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

FDA Voice

FDA voice is the official blog from FDA's senior leadership and staff.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