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.

November 6, 2013

PRODUCT SAFETY

Drug Safety Communication:Low Molecular Weight Heparins - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis

FDA is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. More information

Class I Recall: Edwards Lifesciences LLC, EMBOL-X Glide Protection System - Deformed Cannula Tip

When force is applied to the tip during insertion or removal, it may lead to a separation and embolize. Use of this recalled product may cause serious adverse health consequences, including death. More information

Recall: Perrigo Acetaminophen Infant Suspension Liquid - Potential Defect with Co-packaged Oral Syringe

The Perrigo Company announced that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under store brand products including Babies R Us, Care One and more. More information

MedWatch September 2013 Safety Labeling Changes

The MedWatch September 2013 Safety Labeling Changes posting includes 49 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. More information

Drug Safety Communication: Potiga (Ezogabine) - Linked To Retinal Abnormalities And Blue Skin Discoloration

FDA approved changes to the drug label, underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent. More information

Recall: PENTAX Medical Gas/Water Valves, Model OF-B194: - Manufacturing Defect

PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/ Water Valves, model OF-B194. More information

Drug Safety Communication: Iclusig (Ponatinib) - Increased Reports Of Serious Blood Clots In Arteries And Veins

FDA has asked, and Ariad Pharmaceuticals has agreed, to suspend marketing and sales of Iclusig (ponatinib), a leukemia chemotherapy drug, because of the risk of life-threatening blood clots and severe narrowing of blood vessels. 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 AND CLEARANCES

FDA approves Gazyva for chronic lymphocytic leukemia-Drug is first with breakthrough therapy designation to receive FDA approval

FDA approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). More information

FDA Approves Zohydro ER and Responds to CLAAD Citizen Petition

FDA has approved Zohydro ER, the first extended-release, single-entity hydrocodone-containing drug product. To enhance safe and appropriate use, Zohydro ER's labeling reflects the newly required ER/LA opioid analgesic class safety labeling changes and will be subject to the recently announced class postmarket study requirements. FDA also responded to a citizen petition (CP) concerning opioid medications and abuse-deterrence. More information

FDA approves first drug to treat multi-resistant tuberculosis

FDA approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. 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

Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format

This draft guidance provides recommendations for the "Patient Counseling Information" section on the following: How to decide what topics to include in the section, how to present information within the section, and how to format and organize section contents. Submit either electronic or written comments on the draft guidance by November 18, 2013. More information

Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment

The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a previous draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment'' issued on September 14, 2010. Submit either electronic or written comments on the draft guidance by December 23, 2013. More information

Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment

The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination. Submit either electronic or written comments on the draft guidance by February 4, 2014. More information

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff

This guidance document identifies applicable legal requirements under the Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). Hearing aids and PSAPs both affect our ability to hear sound, but the products have different intended uses, and are therefore subject to different regulatory controls. Submit either electronic or written comments on the draft guidance by February 7, 2014. More information

Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff

This guidance describes principles for the design of pre-market clinical studies that are pivotal in establishing the safety and effectiveness of a medical device. Practical issues and pitfalls in pivotal clinical study design are discussed, along with their effects on the conclusions that can be drawn from the studies concerning safety and effectiveness. More information

ANNOUNCEMENTS

Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research

FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse. By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II. More information

FDA takes two important actions on drug shortages

First, the FDA is releasing a strategic plan to improve the agency's response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. More information

FDA Helping to Advance Treatments Tailored to You

To describe its unique responsibilities and its efforts in facilitating the advancement of personalized medicine, the FDA has released a new report entitled "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development (PDF 875 K)."

Truthful Prescription Drug Advertising and Promotion

As part of FDA's Bad Ad program, the Office of Prescription Drug Promotion introduces a new CME/CE e-learning course and case studies to raise health care professionals (HCP) and HCP students' awareness of misleading prescription drug promotion and other common regulatory concerns. 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.

Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (Nov 8)

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Nucleus® Hybrid™ L24 Implant System. More information

Clinical Investigator Training Course (Nov 12, 13, 14)

FDA's Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Nov 13)

The committee will meet in open session via teleconference to hear an overview of the research programs in the Laboratory of Retrovirus Research and the Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More information

Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Nov 13)

The committee will discuss supplemental biologics license application alemtuzumab injection, proposed trade name LEMTRADA. The proposed indication is for the treatment of patients with relapsing forms of multiple sclerosis to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. More information

Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Nov 14)

The committee will discuss new drug application, tasimelteon capsules, proposed trade name HETLIOZ. The proposed indication is for the treatment of Non-24 hour sleep-wake disorder in blind individuals without light perception. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Nov 19)

The committee will discuss biologics license application, Vimizim (elosulfase alfa) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). More information

Public Hearing: Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products (Dec 4)

The purpose of the public hearing is to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency first aid eyewash drug products, More information

Medical Gas Regulation Review; Announcement of Public Meeting (Dec 6)

The topic to be discussed is whether any changes to the Federal drug regulations are necessary for medical gases as part of the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA). More information

Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting (Dec 9)

The committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio). More information

Public Meeting: Fibromyalgia - Patient-Focused Drug Development (Dec 10)

The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Dec 11)

The committee will discuss the safety and efficacy of biologic licensing application, metreleptin for injection. The proposed indication for metreleptin is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy. More information

Allergenic Products Advisory Committee (Dec 11 &12)

The committee will meet in open session to discuss and make recommendations on the safety and efficacy of Oralair and Grastek. More information

FDA/American Gastroenterological Association (AGA) Co-sponsored Public Workshop: Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases (Dec 19 &20)

The purpose of this workshop is to bring together key stakeholders in the development and delivery of new medical technologies. Through this workshop, stakeholders will be able to better clarify their roles and expectations as it pertains to assessing the risk and benefit of medical device procedures, approval, commercialization and coverage. More information

RESOURCES

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

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

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