FDA Updates for Health Professionals

• ANNOUNCEMENTS
• OPPORTUNITIES FOR COMMENT / GUIDANCES
• PRODUCT APPROVALS & CLEARANCES
• PRODUCT SAFETY
• UPCOMING MEETINGS
• RESOURCES

ANNOUNCEMENTS

Webinar - FDA Online Drug Information Resources for Students and Clinicians  (September 29, 2015) Lesley Navin RN, MSN, Advanced Practice Nurse, will present information regarding FDA databases that are of interest to students and practicing clinicians who will learn how to navigate and utilize these databases to find useful, relevant and current drug information. More information

FDA Taking Genomic Testing to the Next Level President Obama’s Precision Medicine Initiative (PMI) envisions a day when the specific differences between people – genetic, environmental, lifestyle – will be used to customize the healthcare that we receive. Many of the current efforts toward achieving this goal have focused on analyzing and interpreting a person’s unique genetic makeup, including the identification of genetic alterations that may impact his or her health. More information

OpenFDA Makes Medical Device-Related Data Easier to Access and Use OpenFDA is a project that provides easy access to the many large, important, health data sets collected by FDA. OpenFDA’s Application Programming Interface (API) expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle. More information

Naming and Biological Products To create market competition among biological products and lower costs, the Affordable Care Act created a new approval pathway for products that are biosimilar to and interchangeable with FDA-licensed biological products. Earlier this year, the agency approved the first biosimilar, and other products are in development. But one key issue is how to name biological products to ensure safe use and foster acceptance of these new products. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Request for comment by September 14, 2015: Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring FDA announced an opportunity for public comment on a guidance that is intended to assist sponsors of clinical investigations in developing strategies for risk-based monitoring and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. The guidance describes strategies for monitoring activities performed by sponsors, or by contract research organizations (CROs), that focus on the conduct, oversight, and reporting of findings of an investigation by clinical investigators. More information

Request for comment by September 28, 2015: Draft Guidance - The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels

The draft guidance, when finalized, will explain FDAs nutrition labeling policy on declaring the nutrient values in conventional foods and dietary ingredient values in dietary supplements in certain cases. Specifically, declaring small amounts of nutrients and dietary ingredients in the nutrition labeling may result in a conflict between 21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 101.9(g)(5). More information

Request for comment by September 30, 2015: Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products

The FDA is extending the comment period for the advance notice of proposed rulemaking (ANPRM) entitled “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products” that appeared in the Federal Register of July 1, 2015. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. More information

Nonproprietary Naming of Biological Products

This guidance describes FDA’s current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. FDA’s current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. More information

Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile

This guideline identifies measures that FDA considers as mitigations to the risks to health associated with these devices and that provide a reasonable assurance of safety and effectiveness. More information 

PRODUCT APPROVALS & CLEARANCES

FDA approves new orphan drug to treat rare autosomal recessive disorder FDA approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.More information

FDA approves new drug treatment for nausea and vomiting from chemotherapy

FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy. More information

FDA approves Repatha to treat certain patients with high cholesterol

FDA approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol. More information

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

PRODUCT SAFETY

Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning FDA expanded its alert regarding compounded or repackaged drugs stored in Becton-Dickinson (BD) general use syringes to include certain additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes. An interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately. More information

UPDATE: Treanda (bendamustine hydrochloride) Solution by Teva - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene

FDA provided information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection. More information

Class I Recall: Puritan Bennett 980 Ventilators by Covidien - Amount of Air Delivered May Be Lower Than Programmed

When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician. If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen can result in possible injury or death. More information

Class I Recall: Evita V500 and Babylog VN500 Ventilators by Dräger Medical - Faulty Batteries

The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted. When the “battery low” and “battery depleted” alarms sound, the devices do not indicate  how much time is left before the ventilator will shut down due to lack of power. More information

DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain

FDA warned that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors. More information

Recall: OmniPod (Pod) Insulin Management System by Insulet Corporation - Possibility of a Higher Rate of Failure

Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System, due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM). More information

Class I Recall: Alaris Syringe Pump by CareFusion - Alarm Error May Cause Interruption of Therapy

An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death. CareFusion has received 108 reports of the issue occurring. More information

Class I Recall: Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump

Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or death. More information

Class I Recall: Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical - Connector May Crack or Separate

Teleflex Medical has received customer complaints about the endobroncial tube’s double swivel connector. The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. This can lead to the need to re-intubate the patient, patient injury or death. More information

Recall: Refresh Lacri-Lube, Refresh P.M., FML 0.1 % and Blephamide 10 %/0.2 % by Allergan: Recall - Particulate Matter

Recall based on a small number of customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product. Specific lots are being voluntarily recalled in the interest of patient safety. If the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation.  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.

FDA Regulatory Education for Industry (REdI) Conference Fall 2015(September 29-30)

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or medical device products who want to learn about how FDA approaches the regulation of drugs and devices. More information

2015 PDA/FDA Joint Regulatory Conference (September 28-30)

The FDA and the Parenteral Drug Association (PDA) are co-sponsoring a public conference to discuss current issues affecting the industry. More information

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting (September 24)

The committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue ingrowth, which over time results in tubal occlusion. More information

Pediatric Advisory Committee Meeting (September 16)

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). More information

Science Board to the FDA (September 15)

The Science Board will be provided with a report from the Science Looking Forward subcommittee.More information

Vaccines and Related Biological Products Advisory Committee (September 15)

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (September 11)

The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (September 10)

The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. More information

Arthritis Advisory Committee Meeting (October 23)

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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

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  

Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with 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