As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs 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.

September 24, 2014

PRODUCT SAFETY

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Recall:Potassium Chloride Injection (Baxter) - Shipping Carton Mislabeling

Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. More information

Recall: Playtex Nurser Deluxe Double Electric Breast Pump - Potential for Electric Shock

UPDATED 09/16/2014. One AC/DC power adapter production lot added to recall. More information

Drug Safety Labeling Changes - August 2014

Includes 32 products with revisions to Prescribing Information. More information

Recall: Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira - Particulate Matter

Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. 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 & CLEARANCES

FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample

FDA allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei. More information

FDA approves Trulicity to treat type 2 diabetes

FDA approved approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. More information

FDA approves Movantik for opioid-induced constipation

FDA approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. More information

FDA approves weight-management drug Contrave

FDA approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. 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

Guidance: Custom Device Exemption

FDA has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). The intent of this guidance is to define terms used in the custom device exemption, explain how to interpret the "five units per year of a particular device type" language contained in the FD&C Act, describe information that FDA proposes manufacturers should submit in the custom device annual report, and provide recommendations on how to submit an annual report for devices distributed under the custom device exemption. Submit either electronic or written comments on this guidance at any time. More information

ANNOUNCEMENTS

New FDA Educational Program: Know Your Source

There is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market. FDA has launched "Know Your Source," an educational program advising health care professionals and practice administrators to only purchase prescription drugs from wholesale drug distributors licensed in your state to protect your patients from unsafe and ineffective drugs. More information

FDA Webinar on the Inclusion of Minorities in Clinical Trials (October 7)

You are invited to participate in a webinar sponsored by the FDA's Office of Minority Health (OMH) on the FDASIA 907 Action Plan to Enhance the Availability and Collection of Demographic Subgroup Data, Increasing participation in clinical trials is a multi-faceted challenge that will require collaboration of our federal partners, industry, health care professionals, patient advocacy groups and community-based organizations. This meeting is the first in an ongoing discussion with stakeholder groups regarding the agency's efforts in this area. Register by Oct. 6. More information

Consumer Update: Don't Leave Childhood Depression Untreated

Some parents might think that medication is the solution for depression-related problem behaviors. In fact, that's not the case. The Food and Drug Administration hasn't approved any drugs solely for the treatment of "behavior problems." When FDA approves a drug for depression—whether for adults or children—it's to treat the illness, not the behavior associated with it. 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.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (October 1)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (October 8-9)

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation's WATCHMAN Left Atrial Appendage (LAA) Closure Technology.On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). More information

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory CommitteeMeeting (October 16)

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk. More information

Dermatologic and Ophthalmic Drugs (October 20)

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. More information

Collaborative Approaches for Medical Device and Healthcare Cybersecurity - Public Workshop (October 21-22)

The purpose of this workshop is to catalyze collaboration among all stakeholders. Participants identify barriers to promoting medical device cybersecurity; discuss innovative strategies to address challenges that may jeopardize critical infrastructure; and enable proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity. This public workshop will also be Webcast. More information

First Annual Neonatal Scientific Workshop - Roadmap for Applying Regulatory Science to Neonates (October 28-29)

The purpose of the public scientific workshop is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public to determine whether there is sufficient interest on the part of stakeholders to develop a neonatal consortium and to discuss potential working groups dedicated to the regulatory science required to develop neonatal therapeutics. More information

Cardiovascular and Renal Drugs Advisory Committee Meeting (October 30)

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart). More information

Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications - Public Meeting (October 30-31)

The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA's approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties.The transition to abuse-deterrent formulations of opioid medications presents a number of complex scientific and regulatory challenges. The purpose of this public meeting is to share and solicit comments on the Agency's ongoing work to identify and address these challenges. More information

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (December 12)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. More information

Electronic Cigarettes and the Public Health - Public Workshop (December 10-11)

The workshop will include presentations and panel discussions about the current state of the science, and will focus on product science, packaging, constituent labeling, and environmental impacts. FDA intends to follow this workshop with two additional electronic cigarette workshops, with one on individual health effects and one on population health effects. More information

RESOURCES

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

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

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