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.

January 29, 2014

The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff. The Office of Health and Constituent Affairs (OHCA) serves as a liaison between the FDA Centers and the public on matters that involve medical product safety. Click here to register!

PRODUCT SAFETY

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Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use

Incorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death. More information

Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. More information

Magic Slim: Public Notification - Undeclared Drug Ingredient

Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review

Production facility in Vietnam reviewing manufacturing sterility controls. More information

StemAlive 90 Capsules: Recall - Contains Undeclared Milk

Risk of serious or life-threatening allergic reaction. 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

PRODUCT APPROVALS & CLEARANCES

FDA allows marketing for first of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children

FDA authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child's developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes. 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 for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information; Availability

This guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. More information

Pediatric Studies of Sodium Nitroprusside Conducted in Accordance With the Public Health Service Act; Availability of Summary Report and Requested Labeling Changes

FDA is publishing a summary report of the pediatric studies of sodium nitroprusside conducted in accordance with the Public Health Service Act (the PHS Act) and is making available requested labeling changes for sodium nitroprusside. More information

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance document describes studies and criteria FDA recommends in premarket submissions for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) use by lay-persons. When finalized, FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types. Submit either electronic or written comments on the draft guidance by April 7, 2014. More information

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance document describes studies and criteria FDA recommends for blood glucose monitoring test systems (BGMSs) which are for prescription point-of-care use. When finalized, FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types. Submit either electronic or written comments on the draft guidance by April 7, 2014. More information

Guidance for Industry on Qualification Process for Drug Development Tools

This guidance describes the qualification process for drug development tools intended for potential use, over time, in multiple drug development programs. The guidance provides a framework for interactions between FDA and sponsors to support work towards qualification of an identified drug development tool and creates a mechanism for formal review of data to qualify the tool and ensure that the evaluation is comprehensive and reliable. More information

Custom Device Exemption; Draft Guidance for Industry and Food and Drug Administration Staff

FDA has developed a draft guidance 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 provide draft definitions of 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 what information 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 the draft guidance by March 17, 2014. More information

Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment

The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination. Submit either electronic or written comments on the draft guidance by February 4, 2014. More information

ANNOUNCEMENTS

FDA launches advisory committee membership nomination portal

FDA launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency's 33 advisory committees. More information

FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor's Statement on the Institute of Medicine Report on Caffeine in Food and Dietary Supplements

FDA thanks the Institute of Medicine (IOM) for convening the Aug. 5-6, 2013, public workshop on caffeine in food and dietary supplements. The summary report that IOM issued will be extremely informative as we continue our investigation of the safety of caffeine, particularly its effects on children and adolescents. More information

Problems with Tobacco Products? Tell the FDA

The FDA wants to hear from you and has a new online tool you can use to report your problem. The Department of Health and Human Services' Safety Reporting Portal (SRP) has been revised to add a new category for tobacco products. This update provides a standardized way for consumers and health care professionals to let FDA know when they suspect that there is an unexpected health or safety issue with a specific tobacco product. More information

FDA Commissioner Margaret A. Hamburg's Statement on the 50th Anniversary Surgeon General's Report on Smoking and Health

The 50th anniversary of the release of the Surgeon General's Report on Smoking and Health is an opportunity to reflect on the important progress that has been made in tobacco control and to look ahead on addressing this critical public health issue. In 2014, tobacco remains the leading preventable cause of disease and death in this country. For five decades, the Department of Human Health and Services has played a critical role in developing and implementing proven comprehensive tobacco control programs and policies aimed at preventing tobacco use, especially among youth, and encouraging cessation. More information

Free Resources Help People Stick to Their Prescriptions

More than 125,000 Americans die each year from not taking their medications properly. Many others experience worsening chronic health conditions because of it. With free educational tools from the Food and Drug Administration and the Script Your Future Campaign, you can help the people in your community keep track of their prescriptions and when to take them. And you can help them learn to talk with their pharmacist about the concerns or questions that might be keeping them from taking their medications as prescribed.

Don't miss out — order your free resources in bulk today to share with your community.

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.

Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee (Feb 10-11)

The committees will discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling. More information

Cardiovascular and Renal Drugs Advisory Committee Meeting (Feb 12-13)

On Feb. 12, the committee will discuss new drug application (NDA) 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). More information On Feb. 13, the committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure. More information

Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 14)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company. More information

Public Workshop – Biofilms, Medical Devices and Anti-Biofilm Technology – Challenges and Opportunities (Feb 20)

This State of the Art public workshop seeks to share scientific information between the academic and healthcare communities, industry interested in developing products to address biofilm contamination, and US Government scientists. FDA is co-sponsoring this workshop with the Center for Biofilm Engineering (CBE) of Montana State University. Persons interested in attending this public workshop must register online by 5 p.m. February 7, 2014 More information

Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop (Mar 12-13)

The public workshop 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

Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (Mar 12)

The committee will discuss, make recommendations, and vote on a premarket approval application for a new indication for the cobas Human Papillomavirus (HPV) Test, sponsored by Roche Molecular Systems, Inc. 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 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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