FDA Updates for Health Professionals

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

ANNOUNCEMENTS

FDA’s improved, mobile-friendly web site specifically designed to the needs of busy clinicians Visit “For Health Professionals” at www.fda.gov/ForHealthProfessionals. You’ll find FDA content tailored to the interests of doctors, nurses, pharmacists, and other healthcare professionals. More information

A Global Fight Against Dangerous Counterfeit and Unapproved Medical Products: From Operation Pangea to FDA’s Global Strategic Framework. FDAVoice Blog

Unfolding earlier this month was a global cooperative effort, which included the Food and Drug Administration, to combat the online sale and distribution of potentially counterfeit and illegal medical products. Operation Pangea VIII was a project of massive scope, a lightning move by 115 countries that resulted in more than 2,400 websites being taken offline and the seizure of $81 million worth of potential dangerous illegal medicines and medical devices worldwide.  More information

Naloxone – FDA hosts meeting to discuss expanded use of overdose medicine: FDAVoice Blog

The drug, which literally dislodges opioid drugs such as heroin or oxycodone from their receptors, thus reversing overdoses in minutes, has increasingly been administered outside of conventional medical settings by community and family members, as well as by first responders such as police and fire departments. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Request for Comments: Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products FDA is issuing advance notice of proposed rulemaking (ANPRM), seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. More information

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy - Guidance for Industry

For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582(d)(1) of the FD&C Act go into effect on July 1, 2015. More information

Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments

This document is intended to assist industry and FDA staff to understand FDA's requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of “reprocessing” for purposes of UDI direct marking requirements. More information

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings

This draft guidance clarifies and describes the premarket regulatory requirements pertaining to gowns regulated under 21 CFR 878.4040 and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. More information

Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus

FDA is announcing the issuance of an Emergency Use Authorization (EUA) for an vitro diagnostic device for detection of Enterovirus D68 (EV-D68) strains detected in North America in 2014. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves new antiplatelet drug used during heart procedure FDA approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle. More information

FDA allows marketing of new device to help the blind process visual signals via their tongues

The FDA allowed marketing of the BrainPort V100, a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. More information

FDA approves SAPIEN 3 THV artificial heart valve

Tthe SAPIEN 3 Transcatheter Heart Valve (THV) was approved for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery. 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.

Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality Unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use. More information

Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - Potential for Serious Side Effects, Including Slowed or Difficulty Breathing

FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficulty breathing. FDA is evaluating all available information and will also consult with external experts by convening an Advisory Committee to discuss these safety issues. More information

Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes

FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. More information

Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models

Medtronic notified hospitals and distributors worldwide that affected lots of its Covidien Shiley tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels, immediately upon tube placement or discomfort. More information

HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall

Heartware recently conducted multiple recalls for this device. The FDA will update this page as new information becomes available. More information

M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues

A process monitoring failure led to higher than expected amounts of manufacturing residues left on the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. 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 Meeting: Exploring Naloxone Uptake and Use (July 1-2)

FDA in collaboration with the National Institutes of Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, is announcing a scientific workshop to initiate a public discussion about issues surrounding the uptake of naloxone in certain medical settings – such as on ambulances and in association with prescriptions for opioids – as well as outside of conventional medical settings to reduce the incidence of opioid overdose fatalities. Academia, government, industry experts, and patient advocates will discuss which populations are at risk for opioid overdose and how public health groups can work together to use naloxone to reduce the risk of overdose. We will also explore legal, regulatory, logistical and clinical aspects related to making naloxone more widely available. More information

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 7-8)

The committees will discuss the results of post marketing studies evaluating the misuse and/or abuse of reformulated Oxycontin (oxycodone hydrochloride) extended-release tablets, supplemental new drug application (sNDA) 022272, manufactured by Purdue Pharma L.P. The committees will discuss whether these studies have demonstrated that the reformulated Oxycontin product has had a meaningful impact on abuse of Oxycontin. More information

Oncologic Drugs Advisory Committee (Jul 9)

The committee will discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer. More information

Public Meeting: Medical Device User Fee Reauthorization (Jul 13)

FDA will hold a public meeting to gather initial input on reauthorization of the Medical Device User Fee program, as required by section 738A of the Federal Food, Drug, and Cosmetic Act. Additional information and Federal Register announcement available. More information

Public Meeting: Prescription Drug User Fee Reauthorization (Jul 15)

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in developing recommendations for the next PDUFA program (FY2018-2022). More information

Public Workshop: Robotically-Assisted Surgical Devices - Challenges and Opportunities (Jul 27-28)

The purpose of this workshop is to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS technologies. The participants of this workshop will discuss current challenges and opportunities related to RAS devices and address clinical, technical and training questions related to the safe and effective use of these devices. More information

There are currently no meetings scheduled for August 2015.

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