As part of our ongoing efforts to keep you informed about the U.S. Food and Drug Administration, 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.

May 6, 2015

ANNOUNCEMENTS

Evaluating the changing landscape of health care antiseptics

Colleen Rogers, Ph.D., Lead Microbiologist in FDA’s Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products discusses the frequent use of health care antiseptics and the need for updated safety and efficacy data. More information

AccessGUDID: Identify your Medical Device

The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). In collaboration with the National Library of Medicine, the FDA has created a portal, AccessGUDID, to make device identification information in the GUDID available for everyone--including patients, caregivers, health care providers, hospitals, and industry. More information

Congratulations to FDA’s Dr. Richard Pazdur, recipient of the AACR’s prestigious Distinguished Public Service Award

In the past five years, FDA’s Center for Drug Evaluation and Research (CDER) has approved more than 40 novel cancer treatments, offering hope to many patients who previously had few or no treatment options. Among these products are new and cutting-edge targeted therapies—sometimes called “precision medicines”—tailored to treat patients based on their individual characteristics. This achievement is a tribute to the dedicated CDER scientists and clinicians who support innovative development of cancer drugs, and evaluate the safety and effectiveness of new products for FDA approval. They are led by the dynamic and creative thinker, Dr. Richard Pazdur, a 16-year FDA veteran whose name has become synonymous with excellence in cancer drug research, development, evaluation and approval. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

FDA has posted a draft guidance that provides a framework under which to consider extrapolating existing adult clinical medical device data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs) and humanitarian device exemptions (HDEs). This draft guidance facilitates continued efforts to address the unmet medical device need for pediatric patients. The comment period opened today, May 6, 2015, and will be open for 90 days. More information

Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions

The Food and Drug Administration is introducing a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMAs) or de novo requests. The comment period opened on April 14th, 2015. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves Raplixa to help control bleeding during surgery

Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. More information

FDA approves treatment for fat below the chin

Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.. More information

FDA approves first generic Abilify to treat mental illnesses

Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms. More information

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed

PRODUCT SAFETY

Need Safety Information?

For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Mucinex Fast-MAX Products: Recall - Incorrect Labeling

RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. More information

Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing

The FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not been demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection. More information

Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials

Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary). More information

Injectable Products by Mylan: Recall - Presence of Particulate Matter

Mylan N.V. is conducting a voluntary nationwide recall to the hospital/user level of select lots of injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples. More information

Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems

On April 24, 2015, the FDA required the facility to notify all patients who received mammograms at Coastal Diagnostic Center any time on or after February 24, 2013, and their referring health care providers, about the problems with the mammography quality at the facility. More information

Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter

Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. 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.

Patient Focused Drug Development for Functional Gastrointestinal Disorder (May 11)

The FDA is holding a public meeting and an opportunity for public comment on Patient-Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. More information

The committee will meet in open session to discuss the development and licensure of Ebola vaccines.More information

Pulmonary-Allergy Drugs Advisory Committee (May 12)

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. More information

Blood Products Advisory Committee (May 13)

The committee will meet in open session to discuss strategies for implementation of serological and nucleic acid testing for Babesia microtiin blood donors. In the afternoon, the committee will hear update presentations on the following topics: 1) FDA considerations for Hemoglobin S Testing in blood donors; and 2) FDA considerations for a revised blood donor deferral policy for men who have sex with men. Following the update presentations, the committee will hear presentations on the research programs of the Laboratory of Cellular Hematology, Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. More information

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee (May 14-15)

The committee will discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States. More information

Food and Drug Administration Science Forum 2015; Public Workshop (May 27-28)

The purpose of the public workshop is to highlight science conducted at the FDA by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The focus of the forum will be the eight FDA Regulatory Science priority areas. More information

Transmissible Spongiform Encephalopathies Advisory Committee (Jun 1)

The committee will meet in open session to hear update presentations on the following topics: 1) the variant Creutzfeldt-Jakob Disease (vCJD) situation worldwide and an update on the United Kingdom’s Transfusion Medicine Epidemiological Review; 2) vCJD in the United States; and 3) the bovine spongiform encephalopathy (BSE) situation worldwide and the United States Department of Agriculture’s regulatory approaches to reduce the risk of food-borne exposure of BSE. More information

Endocrinologic and Metabolic Drugs Advisory Committee (Jun 9-10)

The committee will discuss the safety and efficacy of biologics license application (BLA) 125522, proposed trade name REPATHA (established name: Evolocumab) and the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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 endruginfo@fda.hhs.gov. Comunicaciones de la FDA

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