As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs (formerly the Office of Special Health Issues) wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.

May 22, 2013

PRODUCT SAFETY

Recall: Methotrexate Sodium, USP Injectable Vials by Sandoz US - Particulate Matter In Vials

Particulate matter in parenteral drugs has been recognized as a potential health hazard. More information

Class 1 Recall: Abbott Diabetes Care - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result

Incorrect test results at extremely high blood glucose levels. More information

Recall: All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility - Lack Of Sterility Assurance

If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection. More information

Recall: Compounded Prescription Therapies By Pentec Health Inc. - Lack Of Sterility Assurance

Patients are at increased risk of infection in the event a sterile product is compromised. More information

Safety Labeling Changes: April 2013

Includes 48 products with revisions to Prescribing Information.More information

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products. More information

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

UPDATED 05/13/2013. Additional Recall information available. Risk of serious infection to patients. 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 Simponi to treat ulcerative colitis

FDA approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. More information

FDA approves new drug for advanced prostate cancer

FDA approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. More information

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer

FDA approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC). More information

FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease

FDA approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 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

Request for Comment: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products

FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. Submit either electronic or written comments on this proposed order by August 7, 2013. More information

510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting; Request for Comments

FDA is holding this meeting on June 13, 2013, from 9 a.m. to 5 p.m. to obtain information on its interpretation of the 510(k) device modifications regulations, and specifically, deciding when a 510(k) should be submitted for a change to a 510(k)-cleared device. To permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the meeting topics. FDA would like to receive these comments by May 30, 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

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

ANNOUNCEMENTS

Consumer Update:Stay Safe in the Summer Sun

Did you know that some sunscreens protect against only the sun's ultraviolet B (UVB) rays and not its ultraviolet A (UVA) rays, which also contribute to skin cancer? That no sunscreen completely blocks UV radiation, and that other protections are needed too? That no sunscreens are waterproof? 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

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.

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 Endocrinilogic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Jun 5-6)

On both days, 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

Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 13)

The committee will discuss and make recommendations regarding the possible reclassification of influenza detection devices, currently regulated as class I. More information

Public Meeting: HIV Patient-Focused Drug Development and HIV Cure Research (Jun 14)

FDA is announcing a public meeting and an opportunity for public comment on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. 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

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting(Jun 27)

The committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. More information

Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 17)

The committee will discuss the safety and efficacy for the new drug application (NDA) 203077, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, submitted by QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. More information

Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (Jul 25-26)

FDA is announcing a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. 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 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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