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.

August 28, 2013

PRODUCT SAFETY

Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling

Aidapak Services LLC, is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company's website. The Firm voluntarily recalled these products to the hospital/user level after learning of possible incorrect labeling which could involve OTC, prescription, and dietary supplement products. More information

FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories

FDA is advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating. More information

Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Wellness Pharmacy, Inc. issues nationwide voluntary recall of certain sterile products due to laboratory results indicating microbial contamination. If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening. More information

JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor

JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by FDA of Front Range Laboratories of Loveland, Colorado, one of the contract testing labs used by JCB. More information

Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance

Park Pharmacy & Compounding Center is voluntarily recalling two lots of products Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection, to the consumer level. In a recent inspection, FDA investigators observed that methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. More information

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

FDA is reminding health care providers about safety concerns with all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. Health care providers should not administer any NuVision Pharmacy sterile products to patients because the products' sterility is not assured. NuVision Pharmacy has repeatedly declined to recall its sterile products. More information

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage

FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. More information

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding. More information

Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper

Covidien announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. More information

Ortiga: Public Notification - Contains Hidden Drug Ingredient

FDA is advising consumers not to purchase or use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple websites, including Ebay, and in some retail stores. More information

Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients

Jack Rabbit Inc. announced that it is conducting a voluntary nationwide recall of one lot of the company's dietary supplement product sold under the name Jack Rabbit. FDA lab analysis of the product was found to contain Sildenafil and Tadalafil, which are active ingredients of FDA-approved drugs for erectile dysfunction, making Jack Rabbit an unapproved drug. More information

Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients

Herbal Give Care LLC is voluntarily recalling all lots of Esbelder man (30 capsules), Esbelder fem (30 capsules) and Esbelder siloutte (30 capsules) to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. More information

Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient

Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) and sildenafil is not listed on the product labels. 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

New test system identifies 193 different yeasts and bacteria known to cause illness

The U.S. Food and Drug Administration allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute. 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

Secure Supply Chain Pilot Program

FDA is announcing the start of the Secure Supply Chain Pilot Program (SSCPP). The SSCPP is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks. This notice outlines the eligibility requirements and the process for applying for participation in the SSCPP. FDA will be accepting applications for participation in the SSCPP beginning September 16, 2013, and continuing through December 31, 2013. More information

Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry

This guidance document is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information to be included in FDA premarket submissions for such devices. More information

Reopening of Comment Period:Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research

FDA requested public comment regarding patients' perspective on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and issues related to HIV cure research. FDA is reopening the comment period to allow interested persons additional time to submit comments. Comments are due by September 3, 2013. More information

Request for Comments: Testing Communications on Medical Devices and Radiation-Emitting Products

This notice solicits comments on communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health. Comments are due by September 09, 2013. More information

Request for Comments: Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138

On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) into law. Section 1138 of FDASIA requires that FDA review and modify, as necessary, the FDA communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.Section 1138 of FDASIA requires that FDA shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of FDA, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan. Comments are due by September 9, 2013. More information

Request for Comments: Administrative Detention of Drugs Intended for Human or Animal Use

FDA is proposing a regulation to implement administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Comments are due by September 13, 2013. More information

Request for Comments: Format and Content Requirements for Over-the-Counter Drug Product Labeling

This notice solicits comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Submit comments by September 23, 2013. More information

Request for Comments: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research

FDA is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine's (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. Comments are due by September 30, 2013. More information

Request for Comments: Menthol in Cigarettes, Tobacco Products

FDA is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. FDA is also making available its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes.Comments are due by September 23, 2013. More information

ANNOUNCEMENTS

Consumer Update: Hyperbaric Oxygen Therapy: Don't Be Misled

Hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA. 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.

Public Workshop: Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis (Sept 5 & 6)

FDA's Center for Drug Evaluation and Research in cosponsorship with the American Association for the Study of Liver Diseases is announcing a 2-day public workshop entitled "Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic fatty liver disease (NAFLD)." This workshop will provide a forum to discuss trial design, including endpoints for clinical trials in NAFLD, to promote efficient drug development in this area and thus improved treatments for patients. More information

Pediatric Ethics Subcommittee of the Pediatric Advisory Committee (Sept 9 & 10)

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss ethical issues in pediatric product development, including medical counter measures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks under 21 CFR 50.54. More information

Public Meeting: FDA Patient Network Annual Meeting; Demystifying FDA - An Exploration of Drug Development (Sept 10)

This meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. More information

Circulatory System Devices Panel of the Medical Devices Advisory Committee

(Sept 11 & 12)

The committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor, external pacemaker pulse generators, and membrane lung for long-term pulmonary support systems. More information

Oncologic Drugs Advisory Committee (Sept 12)

The committee will discuss supplemental biologics license application with the trade name PERJETA (pertuzumab) injection. The proposed indication for this product is in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 -positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin, and cyclophosphamide or carboplatin. More information

The Patient Preference Initiative: Incorporating Patient Preference Information Into the Medical Device Regulatory Processes: Public Workshop; Request for Comments (Sept 18 & 19)

The purpose of the workshop is to discuss ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health regulatory decision making. It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. More information

Pediatric Advisory Committee (Sept 19 & 20)

The Pediatric Advisory Committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the for Pediatric Research Equity Act. More information

Food Advisory Committee (Sept 23 & 24)

The Food Advisory Committee will discuss detection signals for noteworthy chemical hazards in foods, dietary supplements, and cosmetics and consider possible sources of information, data on chemical hazards, and how CFSAN might recognize and best take advantage of those data. More information

Narcolepsy Public Meeting on Patient-Focused Drug Development (Sept 24)

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

Great Lakes cGMP & Regulatory Science Forum (Sept 24-25)

This 2-day forum in Chicago, IL will feature experts from FDA, industry, and academia who will discuss the current initiatives to enhance regulatory science, pharmaceutical manufacturing and product quality. More information

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

(Sept 25)

The committee will discuss optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. FDA will seek input on: (1) Best practices in DDI communication through prescription drug product labels, namely: (a) Appropriate format for presentation of DDI information; (b) level of detail of DDI study results; and (c) appropriate wording for clinical recommendations based on empirical data versus anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users in decision making and/or communication. More information

Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop (Oct 7)

The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products. More information

Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Oct 16)

The committee will discuss the supplemental new drug application, Vascepa (icosapent ethyl) Capsules. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase to reduce triglycerides, non-high-density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol and very-low-density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent. More information

Anti-Infective Drugs Advisory Committee Meeting (Oct 17)

The purpose of the meeting is to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. More information

Anti-Infective Drugs Advisory Committee (Oct 18)

The committee will discuss the safety and effectiveness of new drug application, miltefosine capsules, for the proposed indication of treatment of patients with visceral, mucosal, and cutaneous leishmaniasis, an infection caused by a parasite. More information

Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop (Oct 21 & 22)

FDA Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II)." Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. More information

Cellular, Tissue and Gene Therapies Advisory Committee (Oct 22 & 23)

The Committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. The Committee will also hear updates on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products. More information

Third Annual Food and Drug Administration Health Professional Organizations Conference (Oct 24)

FDA is announcing a conference for representatives of Health Professional Organizations. Topics on the agenda include FDA Updates, an overview of FDA's Network of Experts (public/private partnerships), and a FDA Town Hall. The FDA Town Hall will feature FDA senior executives including Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health; Douglas C. Throckmorton, M.D., Deputy Director for Regulatory Programs of the Center for Drug Evaluation and Research; and Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine. More information

RESOURCES

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

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