FDA Product Safety Notices (4-24-2013)

PRODUCT SAFETY

Safety Labeling Changes: March 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 Class I Recall: GE Healthcare, Giraffe OmniBed and Giraffe Incubator – Device May Randomly Delete Stored Information When Powered On The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new information in its place (over-write) when the device turns “on” or recovers from a power failure. More information Class I Recall: LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter -  Failure To Provide Warning At extremely high blood glucose levels of 1024 mg/dL and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 600 mg/dL” as intended. More information Safety Communication: Medical Bed Mattresses – Damaged or Worn Covers Pose Risk of Contamination and Infection From January 2011 to January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress (fluid ingress). Fluid ingress may occur if mattress covers become worn or damaged from small holes or rips in the fabric or from incorrect cleaning, disinfecting and laundering procedures. More information Recall: All Sterile Compounded Products by Nora Apothecary And Alternative Therapies – Lack of Sterility Assurance Nora Apothecary & Alternative Therapies announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.  More information Class I Recall: CareFusion Alaris PC Unit with Software V9.12 – Communication Error When Attached to EtCO2 or SpO2 Modules CareFusion Corporation has received reports of customers experiencing a communication error on the Alaris PC unit (model 8015) with software version 9.12 when attached to the Alaris EtCO2 module (model 8300) or the Alaris SpO2 module (models 8210 and 8220).The firm issued a recall notification letter informing affected customers. More information Recall: Balanced Solutions All Sterile Compounded Products – Lack of Sterility Assurance Balanced Solutions Compounding Pharmacy, LLC announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance. More information Class I Recall:  Stryker OrthSopaedics – ShapeMatch Cutting Guide FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. More information Recall: Sterile Products Compounded, Repackaged, and Distributed by ApothéCure – Sterility Assurance Concerns   ApothéCure, Inc. is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes.  More information Recall: Lyophilized Products Compounded by NuVision Pharmacy – Sterility Assurance Concerns NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection. More information       Recall: Green Valley Drugs: Recall of All Lots of All Sterile Products – Quality Control Concerns Green Valley Drugs notified healthcare professionals and their organizations about the recall of all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. 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 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

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

PRODUCT APPROVALS

FDA approves abuse-deterrent labeling for reformulated OxyContin FDA approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting). More information

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

OPPORTUNITIES FOR COMMENT / GUIDANCES

FDA Wants Your Opinion on Dairy-Product Labels If you’re a lover of chocolate milk, but want to watch your weight, you might reach for the carton labeled “reduced calorie.”  But dairy manufacturers would rather that the carton simply say “chocolate milk.” A petition from Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) calls for FDA to change the “standard of identity” for milk. Federal Register remains open for comment until May 21, 2013.  More information

 

 

 

Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability

FDA is announcing the availability of a draft guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”Submit either electronic or written comments on the draft guidance by June 24, 2013. More information

 

Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use

 

FDA is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. More information

 

Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide

 

FDA is announcing the availability of two guidances for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies” and “Safety Reporting Requirements for INDs and BA/BE Studies—Small Entity Compliance Guide.” These guidances are intended to help sponsors and investigators comply with the requirements for IND safety reporting and safety reporting for BA and BE studies. Submit either electronic or written comments on Agency guidances at any time. More information

 

Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments

 

FDA is announcing the availability of a draft 5-year plan describing the Agency’s approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA’s commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Comments are due by May 7, 2013. More information

 

 

 

FDA proposes new food safety standards for foodborne illness prevention and produce safety; Request for Comments FDA proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules.  Comments are due by May 16, 2013. More information     Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding Regulations   FDA is inviting comments from the public on whether any potential changes to the Federal drug regulations are necessary for medical gases. Comments are due by May 21, 2013 More information  Agency Information Collection Activities; Proposed Collection; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act; Request for Comments   This notice solicits comments on submission of rotational plans for health warning label statements for smokeless tobacco products. Comments are due by May 17, 2013. More information   Draft Guidance for Industry and Food and Drug Administration Staff – Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex   The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container.  FDA is concerned that statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Comments are due by June 10, 2013.  More information

Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System – Request for Comments   FDA is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). Comments are due by June 24, 2013.  More information   Center for Drug Evaluation and Research Medical Policy Council; Request for Comments FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA’s Center for Drug Evaluation and Research (CDER). These comments will help the Agency identify and address medical policy issues that need clarification through guidance, notice and comment procedures, or other means. Comments are due by July 16, 2013. More information     Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4 FDA is announcing the availability of draft guidance for industry and FDA staff entitled “Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4.” Comments can be submitted either electronic or written comments on the draft guidance by July 2, 2013.  More information

ANNOUNCEMENTS

New FDA Patient Network Website Help FDA Help Patients Have A Bigger Voice. The FDA Patient Network has been designed from the ground up to focus entirely on patients. More information FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool FDA announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3. More information Request For Nominations To The Steering Committee For The Reagan-Udall Foundation Innovation In Medical Evidence Development And Surveillance Program The Reagan-Udall Foundation for the FDA is requesting nominations for its Innovation in Medical Evidence Development and Surveillance (IMEDS) Steering Committee. The IMEDS Steering Committee will provide oversight and guidance of the IMEDS Program, and will report to the Reagan-Udall Foundation for the FDA’s Board of Directors. More information Q & A on DMAA in Dietary Supplements DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient found illegally in some dietary supplements and often touted as a “natural” stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. More information

MedWatcher Mobile Application MedWatcher is a mobile application (app) that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet. The app makes it easier and faster for healthcare professionals, patients and caregivers to send voluntary reports of medical device problems to the FDA, compared to the traditional reporting methods – mail, phone or online. More information

Determination That the Oxycontin (Oxycodone Hydrochloride) Drug Products Covered by New Drug Application 20-553 Were Withdrawn From Sale for Reasons of Safety or Effectiveness

FDA has determined that OXYCONTIN (oxycodone hydrochloride) extended-release tablets (10 milligrams (mg), 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg) approved under new drug application (NDA) 20-553 were withdrawn from sale for reasons of safety or effectiveness. More information

Making Health and Health Care Equal for All

What exactly are health disparities? And how can they be reduced or eliminated? At FDA, achieving equality in health and health care is part of the mission of the Office of Minority Health (OMH). More information

FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical product safety

FDA is requesting a budget of $4.7 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food. More information

The FDA Office of Special Health Issues Has a New Name!   The former Office of Special Health Issues, the FDA’s flagship contact for patients and healthcare professionals, will now be called the Office of Health and Constituent Affairs (OHCA). The Office will continue its core function of serving the needs of patients and healthcare professionals and managing the MedWatch program, but the new name showcases the emphasis placed on building a more robust and centralized office for all stakeholder engagement. More information

Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015

FDA is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development.It provides a more systematic approach for the Agency to obtain patients’ input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. More information

Center for Devices and Radiological Health: Experiential Learning Program

 

FDA Center for Devices and Radiological Health (CDRH) is announcing an invitation for participation in its Experiential Learning Program (ELP). The purpose of this document is to invite medical device and health care facilities to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the program. Comment period ends May 2, 2013. More information

 

Pediatric Device Consortia Grant Program

 

FDA is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia (PDC) Grant Program. The goal of the PDC Grant Program is to facilitate the development, production, and distribution of pediatric medical devices. Application due date is June 1, 2013. More information

UPCOMING MEETINGS

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.

Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop (Apr 25-26)   A public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. More information

 

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (Apr 25-26)

 

The committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays,  phencyclidine (PCP) enzyme immunoassays, PCP radioimmunoassays, and isoniazid test strips. More information

 

 

Risk Communications Advisory Committee Meeting (Apr 29-30)

 

The Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA’s adverse event reporting systems, and messaging in the context of competing communicators. More information

Accessible Medical Device Labeling in a Standard Content and Format Public Workshop (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

Oncologic Drugs Advisory Committee Meeting (May 2)   The committee will discuss NDA 204408, with the established name tivozanib capsules, indicated for the treatment of advanced renal cell carcinoma, and NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), indicated for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.  More information

 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (May 2)

 

The committee will discuss the premarket approval application for Juvéderm Voluma XC, indicated for deep (dermal/subcutaneous and/or submuscular/supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement. More information

 

Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (May 3)

 

The committees will discuss the safety and efficacy of currently approved leukocyte growth factors as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. More information

 

Vaccines and Related Biological Products Advisory Committee Meeting (May 8)

 

The committee will meet in open session via teleconference to hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More information

 

Summit on Color in Medical Imaging; Cosponsored Public Workshop (May 8-9)

 

FDA and cosponsor International Color Consortium are announcing the following public workshop entitled “Summit on Color in Medical Imaging: An International Workshop on the Technical Framework for Consistency and Interoperability Approaches for Dealing with Color in Medical Images.” The purpose of the workshop is to bring together key stakeholders to clearly identify areas of need, investigate solutions, and propose best-practice approaches. More information

 

Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice Conference (May 15-16)

 

FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference on FDA’s clinical trial requirements is designed to aid the clinical research professional’s understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. More information

 

 

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (May 21-22)

 

On May 21, the committee will discuss the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. On May 22, the committee the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (Docket No. FDA-2009-M-0101).  More information

 

Peripheral and Central Nervous System Drugs Advisory Committee Meeting

(May 22)

 

The committee will discuss new drug application for Suvorexant tablets. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.  More information

 

Reagan-Udall Foundation Public Meeting (May 23)

 

The Reagan-Udall Foundation for the Food and Drug Administration, which was created by Title VI of the Food and Drug Amendments of 2007, is announcing an annual open public meeting. The Foundation will provide an overview of its history, project updates, as well as projected activities going forward. More information

2013 Medical Countermeasures Initiative Regulatory Science Symposium (May 30)

 

FDA is announcing the following meeting: 2013 Medical Countermeasures initiative (MCMi) Regulatory Science Symposium. The symposium is intended to provide a forum for the exchange of ideas for medical countermeasure development, highlight work on regulatory science as it applies to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure.  More information

Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Jun 5-6) The committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. More information

 

 

Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12)

 

FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information

 

Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24)

 

FDA is announcing the following public workshop: “The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women.” CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. More information

 

Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12)

 

FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information

 

Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24)

 

FDA is announcing the following public workshop: “The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women.” CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. More information

RESOURCES

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

FDA Product Safety Notices (4-24-2013)