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.

August 13,  2014

PRODUCT SAFETY

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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: Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials - Presence Of Particulate Matter Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. See the Press Release for a listing of affected lot numbers. More information

Class I Recall: IPM Wound Gel by Edwards Pharmaceuticals - Microbial Contamination

 IPM Wound Gel Lot # 3P3446 by Wellspring Pharmaceutical Corporation and distributed by Edwards Pharmaceuticals Inc. is being recalled. The lot of IPM Wound Gel may be contaminated with bacteria (Pseudomonas Putida). IPM Wound Gel is used primarily in hospitals for wound care; the over-the-counter IPM Wound Gel is not included in this recall. More information 

FDA Safety Communication: Expression Injectable by Enhancement Medical - Adverse Events Associated with Unapproved Use As a Dermal Filler

FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. More information

Recall: Lidocaine HCI Injection, USP, 2 percent, by Hospira - Visible Particulates

Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.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

FDA approves donor lung preservation device that may result in more lung transplants  FDA approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether the lung is viable for transplantation. More information

FDA approves first non-invasive DNA screening test for colorectal cancer

FDA  approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer. More information

FDA approves Orbactiv to treat skin infections 

Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously. More information

FDA  approves Prestige LP Cervical Disc The Prestige LP Cervical Disc treats one diseased disc in the neck (cervical disc) that causes arm pain and/or weakness or numbness (radiculopathy or myelopathy). The Prestige LP Cervical Disc consists of a titanium-ceramic alloy that fits between the top and bottom surface of the neck bones (cervical vertebrae).  More information

FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements

FDA announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated. More information

FDA approves Jardiance to treat type 2 diabetes

FDA  approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. More information

FDA approves Striverdi Respimat to treat chronic obstructive pulmonary disease

FDA approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time. 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

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 takes steps to help ensure the reliability of certain diagnostic tests FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. FDA is also notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. More information

Filling in Wrinkles Safely In the quest for youth—or at least a more youthful appearance—women and men are seeking treatments to minimize laugh lines, crow's feet, and frown lines, as well as to plump up lips and cheeks. A popular treatment involves injecting dermal fillers into the face. In studies of FDA-approved dermal fillers, people generally report they are satisfied with the outcome of their treatments. 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.

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. OnSeptember 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

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

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