FDA Updates for Health Professionals

January 16, 2013

PRODUCT SAFETY

Recall: Mobius Therapeutics, LLC Issues a Voluntary Recall of Mitosol® (mitomycin for solution), 0.2 mg/vial Kit for Ophthalmic Use Mobius Therapeutics, LLC, St. Louis, MO, announced that it is conducting a voluntary recall of 2 lots of Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use.  These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. More information

Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)

FDA announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. More information

Class I Recall: Fisher and Paykel Healthcare Reusable Breathing Circuit - Pinholes in Tubes

FDA notified healthcare professionals that the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068, was recalled due to pinholes in the tubes used in the reusable breathing circuit. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. More information

Class I Recall: Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units - Risk of Fire Inside Cylinder Unit

Praxair Inc. issued a recall of the Grab 'n Go Vantage Portable Oxygen Cylinder unit because fires may occur inside the cylinder unit causing the wall of the unit to break and release oxygen.  More information

Safety Labeling Changes: December 2012

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. 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 permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis

FDA allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample. 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

Request for Comments: Framework for Pharmacy Compounding - State and Federal Roles

The deadline for submitting comments on the Framework for Pharmacy Compounding: State and Federal Roles docket is January 18, 2013.  The questions for comment  can be located in the Federal Register.  Details about the December 19, 2012 public meeting "Framework for Pharmacy Compounding: State and Federal Roles" are also available.  More information

FDA issues draft guidance on abuse-deterrent opioids

FDA issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.The document explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies. More information

FDA proposes new food safety standards for foodborne illness prevention and produce safety

FDA proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment until May 16, 2013. More information

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising

FDA announced that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising. Fax written comments on the collection of information by January 25, 2013. More information

Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide

FDA announced the availability of two guidances for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies” and “Safety Reporting Requirements for INDs and BA/BE Studies—Small Entity Compliance Guide.” These guidances are intended to help sponsors and investigators comply with the requirements for IND safety reporting and safety reporting for BA and BE studies. Submit either electronic or written comments on Agency guidances at any time. More information 

Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments FDA will be holding a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products.Comments will be accepted until February 12, 2013. More information

ANNOUNCEMENTS

Consumer Update: It's Not Too Late to Get a Flu Shot There is still time to protect your children and yourself from the flu in what remains of a severe influenza season. More information

Seasonal Flu (Influenza) and the FDA

The FDA is responsible for ensuring the safety, effectiveness, and supply of flu vaccines and flu antiviral drugs.  More information

Consumer Update: Breast Pumps: Don't Be Misled - Get the Facts

FDA oversees the safety and effectiveness of these medical devices. The article discusses choosing the right pump and keeping it clean. More information

Webinar: Introduction to FDA's MedWatch Adverse Reporting Program

On January 29, 2013, at 1PM (ET), the Center for Drug Evaluation and Research (CDER), Office of Communication, Division of Drug Information (DDI) will host a webinar titled, “Introduction to FDA's MedWatch Adverse Reporting Program”, the featured speaker, Anna M. Fine Pharm.D., MS, Director, Health Professional Liaison Program in FDA’s Office of Special Health Issues will give an overview of the program,  how to report adverse events to FDA MedWatch, and where to find clinically relevant information from MedWatch. More information

UPCOMING MEETINGS

FDA advisory committe 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.

Cellular, Tissue and Gene Therapies Advisory Committee Meeting (Jan 15) The committee will meet, by teleconference, in open session, to hear updates on the research programs in the Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More information Drug Safety and Risk Management Advisory Committee Meeting (Jan 24-25) On both days, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Jan 29) The committee will discuss olodaterol metered dose inhaler (proposed trade name Striverdi Respimat) by Boehringer Ingelheim, for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Jan 30) The committee will discuss mannitol inhalation powder (proposed trade name BRONCHITOL), by Pharmaxis, for the treatment of cystic fibrosis (CF) in patients aged 6 years and older. More information

Public Hearing - Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need (Feb 4-5) FDA is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. More information Public Hearing - Impact of Approved Drug Labeling on Chronic Opioid Therapy (Feb 7-8) To obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain. More information Risk Communication Advisory Committee Meeting (Feb 12) The Committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception. More information Medical Imaging Drugs Advisory Committee Meeting (Feb 14) The committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. More information Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 22) The committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc.  The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. More information Public Workshop on Minimal Residual Disease (Feb 27) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). More information

Public Workshop on Minimal Residual Disease (Mar 4) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). More information Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee Meeting (Mar 5) The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) outweighs a potential risk of cancer. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7) The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. More information

RESOURCES

Drug Shortages The information provided in this section is provided voluntarily by manufacturers. 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: Flu Vaccines Still Available; Supplies Being Monitored

There is still time to get an influenza vaccine that could protect you during the remainder of the 2012-2013 flu season. 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