August 27, 2014

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 emailsubscribe here. Problem With a Medical Product?  Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form

Upcoming Webinar Learn more about the MedWatch Program, how to submit a report to the FDA and receive safety alerts as soon as they appear on the web site on Thursday, August 28th at 2:30 ET. Registration and more information

Recall: CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical - Risk of Loop to Separate From Shaft Cook Medical recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices, model Number VRS-6.0-9.0. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare. More information

Class I Recall: Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems - Sheath May Fracture During Use

Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems, model number DPB-125MICRO145 (Part number 7-10003), because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly block blood vessels. There are no reported patient injuries to date. More information

July Safety Labeling Changes 

Includes 73 products with revisions to Prescribing Information. More information

Recall: Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II) - Presence of Particulate Matter

Baxter International Inc. announced a voluntary recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall was initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process. 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 endruginfo@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

Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) - H130005 approved

The LVIS Device is a stent and delivery system used to treat certain brain aneurysms. The stent is a self-expanding, nickel-titanium (nitinol) single wire braid. The delivery system consists of an introducer and delivery wire and is used to deliver the stent to the aneurysm. The stent keeps the soft platinum coils that are put into the aneurysm from slipping back into the main blood vessel. More information

FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes

FDA allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease. More information

FDA approves new drug to treat a form of Gaucher disease

FDA approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder. More information

FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer 

FDA  approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer. More information

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

OPPORTUNITIES FOR COMMENT / GUIDANCES

Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs; Reopening of the Comment Period

FDA is reopening the comment period for the draft guidance entitled “Best Practices in Developing Proprietary Names for Drugs,” which published in the Federal Register of May 29, 2014 (79 FR 30852). FDA is reopening the comment period in response to several requests for additional time and to allow interested persons more time to submit comments. Submit comments by September 15, 2014.  More information

Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff

This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. More information

Intent To Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

This draft guidance describes FDA's intent to exempt certain Class II medical devices and certain Class I medical devices, subject to the reserved criteria, from premarket notification requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. More information

Comment Request: Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents

Sponsors for several prescription drug classes market their products directly to vulnerable groups, including adolescents. Such DTC marketing to adolescents raises a variety of potential concerns.More information

Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket

FDA is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. More information

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

FDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications. More information

ANNOUNCEMENTS

FDA warns consumers about fraudulent Ebola treatment products FDA is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. More information

National Action Plan for Adverse Drug Event (ADE) Prevention

The Office of Disease Prevention and Health Promotion (ODPHP), on behalf of the Federal Interagency Steering Committee for Adverse Drug Events, is pleased to release the final version of the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). More information

Allergies to a Legume Called Lupin: What You Need to Know Lupin (sometimes called “lupine”) is a legume belonging to the same plant family as peanuts. “For many people, eating lupin or a lupin-derived ingredient, such as a flour, is safe,” says Stefano Luccioli, M.D., a senior medical advisor at the Food and Drug Administration (FDA). “But there are reports in the medical literature of allergic reactions to lupin, some of which can be severe.”

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.

Nonprescription Drugs Advisory Committee Meeting (September 3-5)

On September 3, the committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. On September 4-5, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. More information

Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments (September 5)

FDA is announcing a public meeting to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in drug and biologic (hereafter referred to as therapeutic product) development programs. The purpose of the public meeting is to initiate constructive discussion and information sharing on the advancement of biomarker science in the context of therapeutic product development among relevant stakeholders. More information

Clinical Development of Drugs for the Prevention of Infections Caused by Staphylococcus aureus in the Health Care Setting; Public Workshop (September 5)

This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of clinical development of drugs to prevent Staphylococcus aureus infections including the design of clinical trials. The input from this public workshop will help in developing topics for further discussion.More information

Cardiovascular and Renal Drugs Advisory Committee Meeting (September 9-10)

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. Also, the committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets, submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting(September 11)

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity. More informaiton

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (September 12)

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism. More information

Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting (September 17-18)

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. More information

Cellular, Tissue and Gene Therapies Advisory Committee Meeting (September 18)

The committee will hear updates of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, the Laboratory of Molecular Oncology and the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, FDA. More information

Pediatric Advisory Committee Meeting (September 23)

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act. More information  

Food Advisory Committee Meeting (September 29-30)

The Committee will provide input to FDA in the development of the characteristics for data collections and risk ranking/risk prioritization models. These characteristics would be useful in framing the fundamental elements needed to design or evaluate FDA's food and veterinary programs. More information

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

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

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