lunes, 18 de febrero de 2013

FDA Updates for Health Professionals

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February 13, 2013


Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower

During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower. More information

Medical Product Safety

St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall - Core Wire May Fracture

FDA notified healthcare professionals of a Class I recall of the St. Jude Medical, AMPLATZER TorqVue FX Delivery System. In a small number of cases, the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. More information

Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk

R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens which are not declared on the labels of individual packets of the product. More information

Safety Labeling Changes: January 2013

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. More information
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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 Comunicaciones de la FDA 
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For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch



FDA Approves New Drug for the Chronic Management of Some Urea Cycle Disorders

FDA approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders in patients ages 2 years and older. More information

FDA Approves Pomalyst for Advanced Multiple Myeloma

FDA approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. More information

FDA Approval of Generic Version of Cancer Drug Doxil is Expected to Help Resolve Shortage

FDA approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection). Doxil is currently on FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages. More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed


Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

To assist FDA in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages. Comments are due by March 14, 2013. More information

Request for Comments: Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use

FDA is announcing the availability of the draft guidance entitled “Design Considerations for Devices Intended for Home Use.” This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Home use devices are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Comments are due by March 13, 2013. More information

Request for Comment: Smokeless Tobacco Product Warning Statement

FDA is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products. Comments are due by April 1, 2013. More information

Request for Comments: Impact of Approved Drug Labeling on Chronic Opioid Therapy

FDA invites comments on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. Comments are due by April 8, 2013. More information



FDA Offers New Guidance on Developing Drugs for Alzheimer’s Disease

FDA issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable (overt) dementia. More information

FDA Commissioner Margaret A. Hamburg’s Statement on the Institute of Medicine’s Report “Countering the Problem of Falsified and Substandard Drugs”

FDA commends the Institute of Medicine for its thorough discussion and recommendations outlined in its report, “Countering the Problem of Falsified and Substandard Drugs.” The report identifies causes and public health consequences of substandard and falsified drugs and recommends a range of strategies to address the problem and to promote global dialogue and action. More information

The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices

February is American Heart Month, and FDA has a tool to help you achieve a heart-healthy lifestyle. More information

Federal Judge Approves Consent Decree with Ben Venue Laboratories

FDA announced that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law. More information

Safe Use Initiative: Acetaminophen Toxicity

Under the leadership of the National Council for Prescription Drug Programs (NCPDP), FDA’s Safe Use Initiative and a broad group of stakeholders came together in 2011 to form the Acetaminophen Best Practices Task Group, which produced Version 1.0 of a White Paper and an update in January 2013, Version 1.1. "NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen, Version 1.1" More information

Webinar: Introduction to Post-marketing Drug Safety Surveillance (Feb 26)

The webinar will give an overview of pharmacovigilance: the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems. This is part 2 of a two part webinar series concerning drug safety. Part 1 was held on January 29, 2013, “Introduction to FDA's MedWatch Adverse Reporting Program”.  The slides and presentation have been archived and are available for viewing. More information 

Webinar: Improved Access to Device Information: What a UDI System can do for Patients and Consumers (Feb 26)

Successful Unique Device Identification (UDI) implementation offers a number of potential benefits for patients and consumers, including faster detection of safety concerns associated with specific devices, more efficient communication between providers and patients regarding important medical device information, and independent patient access to information regarding their devices. More information

Webinar: State of Women's Heart Health

The webinar co-sponsored by The American Heart Association’s (AHA) Go Red For Women and Women Heart: The National Coalition for Women with Heart Disease, featuring remarks by HHS Secretary Kathleen Sebelius, FDA Commissioner Hamburg and representatives from AHA and the Million Hearts Initiative discussing advances in women’s health and actions you can take to reduce risk factors. Register to listen to the archived webinar. More information

Consumer Update: Searching Online for 'Hemorrhoids'?

Whether you consider them a fit topic for conversation or not, it’s evident that Americans want information about hemorrhoids. In 2012, more people searched Google for information on hemorrhoids than on any other health topic. More information

Consumer Update: FDA: Foods Must Contain What Label Says

As someone who cares about what your family eats, you make it a practice when shopping to read the labels on food packages. More information

Consumer Update: Beware of Fraudulent Flu Products

As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public. More information


FDA advisory committe 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.

Neurological Devices Panel of the Medical Devices Advisory Committee (Feb 22)

The committee will discuss, make recommendations and vote on information regarding the premarket approval application for the NeuroPace RNS System.  The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. More information

Public Hearing: Considerations Regarding FDA Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis (Feb 25)

FDA is holding this public hearing to allow patients, caregivers, advocates, health care providers, academia, industry, and other interested persons to give their perspectives on various aspects of the development of drugs for the treatment or management of ALS. The input from this public hearing will help inform the work of FDA offices that review applications for drugs for the treatment of ALS.  More information

Public Workshop - Clinical Flow Cytometry in Hematologic Malignancies (Feb 25-26)

The purpose of this public workshop is to seek input from academia, Government, laboratorians, industry, clinicians, patients and other stakeholders on the role of clinical flow cytometry in hematologic malignancies, in order to develop a specific regulatory policy for this class of in vitro diagnostic devices. More information

Meeting - Science Board to the FDA (Feb 27)

The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to the FDA and its mission, including emerging issues within the scientific community. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Feb 27)

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013-2014 influenza season More information

Public Workshop on Minimal Residual Disease (Feb 27)

FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia. More information
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Public Workshop on Minimal Residual Disease (Mar 4)

FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia. More information

Reproductive Health Drugs Advisory Committee Meeting (Mar 4)

The committee will discuss new drug application (NDA) gabapentin 600 mg tablets for treatment of moderate to severe vasomotor symptoms due to menopause and NDA paroxetine mesylate 7.5 mg capsules for treatment of moderate to severe vasomotor symptoms associated with menopause. More information

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Meeting (Mar 5)

The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include Miacalcin (calcitonin salmon) injection and nasal spray; Fortical (calcitonin salmon recombinant) nasal spray; and the generic equivalents of these products. More information

Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7)

The committee will discuss the new drug application for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA) for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information

Public Conference - Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It? (Mar 20-21)

The conference purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose. More information
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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 5)

The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. More information

Public Workshop - Accessible Medical Device Labeling in a Standard Content and Format (Apr 29-30)

The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. More information


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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 Prouct 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

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