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.

February 12, 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

Need Safety Information?

For more important safety information on human drugs, medical devices, dietary supplements and more, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here.

Problem With a Medical Product?

Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form

Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk

FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. More information

January 2014 Drug Safety Labeling Changes includes 23 products with revisions to Prescribing Information

The MedWatch January 2014 Safety Labeling Changes posting includes 23 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. More information

Recall: Calcium gluconate 10 percent Injections by Rx Formulations - Microbial Contamination

FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations' calcium gluconate injection product. More information

Drug Safety Communication: Testosterone Products - FDA Investigating Risk of Cardiovascular Events

FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. .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 approves pediatric use of Dexcom's G4 Platinum continuous glucose monitoring system

FDA approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older. More information

FDA approves Hetlioz: first treatment for non-24 hour sleep-wake disorder in blind individuals

FDA approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder ("non-24") in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder. 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

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

Draft Guidance for Industry on Analgesic Indications: Developing Drug and Biological Products; Availability

This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain.submit either electronic or written comments on the draft guidance by April 7, 2014. More information

ANNOUNCEMENTS

Why FDA Supports a Flexible Approach to Drug Development

We all know that just as every person is different, so too is every disease and every drug, and so we weren't surprised by the results of a new study published in the Journal of the American Medical Association. The study found that FDA used a range of clinical trial evidence when approving 188 novel therapeutic drugs for 208 indications (uses) between 2005 and 2012. These results are entirely consistent with our regulatory mandate. We believe varying approaches to clinical studies to support drug approval is good news, not bad. More information

Updated FDA requirements for infant formula will maintain high-quality standards and help ensure healthy growth of infants

FDA published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry. More information

Interested in a Science Career at FDA? Our Web Portal Opens the Door

FDA has launched a comprehensive, one-stop web portal – FDA Science Careers and Scientific Professional Development - to showcase FDA's exciting, multidisciplinary scientific work force and culture and how important science is to our public health mission. We want scientists – from students, to recent grads, mid-career, and seasoned professionals – to be aware of the diversity of FDA's career opportunities so that we may continue to attract top scientists, including engineers and medical professionals who want to use their expertise to make a real difference in the world. More information

It's Still Not Too Late to Get Your Flu Vaccine

Meant to get vaccinated in the fall to ward off the flu, but somehow didn't get around to it? Think it's too late to get vaccinated now? Not so. More information

FDA launches its first national public education campaign to prevent, reduce youth tobacco use

FDA announced the launch of a national public education campaign to prevent youth tobacco use and reduce the number of kids ages 12 to 17 who become regular smokers. "The Real Cost" campaign is the FDA's first of several planned tobacco education campaigns using the new authority granted under the Family Smoking Prevention and Tobacco Control Act. More information

PRODUCT SHORTAGES AND DISCONTINUATIONS

FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations.Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov

Drug Shortages Reported by Manufacturers During the Past 2 Weeks:

0.9% Sodium Chloride injection (IV Fluids)

Drug Shortages Resolved During the Past 2 Weeks:

Fluphenazine Deconate Injection
Hydromorphone Hydrochloride Tablets
Isoniazid; Rifampin (Rifamate) Capsules
Levothyroxine Sodium (Levoxyl) Tablets

Drugs to be Discontinued Announced During Past 2 Weeks:

Calcitrol Injection (1mcg/mL)

Drug Shortages Report to Congress

This inaugural report to Congress (PDF-200KB) summarizes the major actions FDA has taken to prevent or mitigate drug shortages in the United States from Jan. 1, to Sept. 30, 2013, and information about shortages that occurred. This report is required under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).

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.

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 STAARR 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

Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary Allergy Drugs Advisory Committee (Feb 25)

The committees will discuss data submitted by Armstrong Pharmaceuticals, Inc., to support a new drug application (NDA) 205920, for over-the-counter (OTC) marketing of epinephrine inhalation aerosol 125 microgram (mcg)/actuation (proposed trade name Primatene HFA), for temporary relief of mild symptoms of intermittent asthma for consumers 12 years of age and older. More information

American Glaucoma Society/Food and Drug Administration Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery; Public Workshop (Feb 26)

FDA is announcing the following public workshop entitled "American Glaucoma Society (AGS)/FDA Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery." This workshop will address the current challenges in the assessment of implantable minimally invasive glaucoma surgical (MIGS) devices with a focus on clinical trial design and conduct. More information

Nonprescription Drugs Advisory Committee (Feb 26)

The committee will meet to discuss whether over-the-counter (OTC) bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest, and wheezing) should be removed from the monograph. Specific drugs to be discussed include epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. More information

Vaccines and Related Biological Products Advisory Committee (Feb 28)

The committee will meet in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2014 to 2015 influenza season. More information

Advancing the Development of Pediatric Therapeutics: Pediatric Bone Health; Public Workshop (Mar 4)

FDA's Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health." The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients.More information

Application of Physiologically-Based Pharmacokinetic Modeling To Support Dose Selection; Notice of Public Workshop; Request for Comments (Mar 10)

The purpose of the workshop is to obtain input on scientific approaches for the conduct and assessment of physiologically-based pharmacokinetic (PBPK) modeling within the framework of drug development and regulatory decisionmaking. The input from the workshop may be used to refine FDA's thinking on the various applications of PBPK. 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

Serious Drug-Induced Liver Injury: Who Gets It? Who Doesn't? Why?; Public Conference; Request for Comments (Mar 19)

This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. Its purpose is to discuss, debate, and share views 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

Public Meeting on Fibromyalgia Patient-Focused Drug Development (Mar 26)

FDA is conducting a public meeting on Patient-Focused Drug Development for fibromyalgia. FDA is interested in obtaining patient input on the impact of fibromyalgia on daily life and patients' views on currently available therapies to treat the condition. This is a rescheduling of the original December 10, 2013 meeting. More information

Anti-Infective Drugs Advisory Committee Meeting (Mar 31)

The committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, and NDA 021-883, dalbavancin hydrochloride for intravenous injection for the proposed indication of treatment of acute bacterial skin and skin structure infections. More information

RESOURCES

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

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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