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.
December 17, 2014
PRODUCT SAFETY
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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.
Includes 30 products with revisions to Prescribing Information. More information
0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter
Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. More information
Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions
A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). More information
Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease
A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. More information
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory
In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed. More information
Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units
Heart Sync Inc. notified customers of a Voluntary Urgent Device Correction for certain Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. 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 first pathogen reduction system to treat plasma
Examples of some of the pathogens that may be reduced using the Intercept Blood System include HIV, hepatitis B and C viruses and West Nile virus. More information
FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency
FDA clears test that helps predict the risk of coronary heart disease
FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women. More information
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer
Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown (progressed) during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy. More information
FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies
FDA approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. More information
FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV
FDA approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). More information
FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
FDA approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition. More information
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia
FDA approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor BA-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. 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
Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
FDA is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. Submit either electronic or written comments by January 18, 2014. More information
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Availability
The draft guidance describes FDA's expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) about reporting to FDA under the DSCSA. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by February 9, 2015 More information
Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads. Submit either electronic or written comments on the collection of information by January 12, 2015.More information
Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements
This study will examine differences between consumers viewing prescription drug ads with a spouse or partner versus alone through empirical research.Submit either electronic or written comments on the collection of information by January 13, 2015. More information
Comment Request: Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products
The term "modified risk tobacco product" means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Submit comments by January 20, 2015. More information
New Clinical Trials Demographic Data; Availability for Comment
FDA is announcing the availability for public comment of Demographic Subgroup Data for FDA Approved Products on FDA's Internet Web site. This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public. Submit electronic or written comments on the content by January 23, 2015. More information
ANNOUNCEMENTS
FDA announces Pharmacy Compounding Advisory Committee members
The committee is comprised of 14 members - 12 voting and two non-voting - who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. More information
2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them By: Margaret A. Hamburg, M.D.
With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013. These numbers include both new molecular entities (NMEs), submitted to CDER in New Drug Applications (NDAs) and new therapeutic biologics submitted to CDER in Biologics License Applications (BLAs). But the numbers don't tell the full story. What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening diseases. More information
CDER Webinar - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
The webinar provides an overview of the reporting requirements for wholesale distributors and third-party logistics providers under DSCSA,describes who must report to FDA, what information should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting to FDA. More information
Rapid Screening of Pharmaceutical Imports in the United States
While most pharmaceutical imports are safe, FDA investigators have discovered toxic metals and other contaminants in imported drug and supplement products. This has led FDA to develop new methods for portable screening devices that quickly identify tainted medicinal imports. 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.
The committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN (filgrastim), submitted by Sandoz, Inc. More information
Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments (Jan 8 & 9)
The purpose of this workshop is to discuss FDA's proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. More information
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (Jan 12)
The committee will discuss the safety and efficacy of new drug application (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void. More information
The committee will discuss new drug applications (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis. More information
Orthopaedic and Rehabilitation Devices Panel (Feb 20)
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
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
Cardiovascular and Endocrine Liaison Program
The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with 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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