UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

ANNOUNCEMENTS

Evaluating FDA’s Approach to Cancer Clinical Trials

Since the announcement of the FDA Oncology Center of Excellence (OCE) two months ago (June 29, 2016) as part of the White House’s Cancer Moonshot, FDA has been working to get new oncology products into the hands of patients.The OCE will leverage the combined skills of oncologists and scientists with expertise in drugs, biologics, and devices to employ the best and most innovative approaches to bring forth safe new oncology products. More information

FDA protects kids from illegal sales of e-cigarettes, e-liquids and cigars

FDA announced it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions. More information

FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths

FDA announced the 2016 Naloxone App Competition, a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.The FDA is inviting computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to create a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone – the antidote for an opioid overdose – thereby increasing the likelihood of timely administration and overdose reversal. More information

On Dauphin Island, FDA Scientists Work to Keep Seafood Safe

On a barrier island in the Gulf of Mexico, two dozen scientists and staff in the FDA’s only marine research laboratory have one common goal: to keep consumers safe from contaminated or unsafe seafood. At FDA's Gulf Coast Seafood Laboratory (GCSL), we use the latest technology to detect and identify things that can potentially contaminate seafood. More information

Search and Rescue: Connecting prescribers to resources to help prevent drug misuse and abuse in their practices

A Partnership for Drug-Free Kids campaign supported by an FDA grant aimed at combatting the nation’s epidemic of opioid misuse and abuse. Resources include information about CME/CE courses, state PDMPs, a fact sheet, a 1-minute abuse screener and videos. More information

Antimicrobial Resistance Information for Health Professionals and Consumers

On September 1-2, 2016, FDA participated in a meeting with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan) to discuss regulatory approaches for the evaluation of antibacterial agents. The EMA, PMDA, and FDA consider that a robust response to the problem of antimicrobial resistance must be multi-faceted and that the regulatory approach for the evaluation of antibacterial agents is only one element of the total response that is required to encourage and accelerate new antibacterial drug development to meet patient needs. More information

First Major FSMA Compliance Dates: Landmarks and Learning Experiences

The phrase “where the rubber meets the road” is one that comes up in conversations about different subjects, from athletics to academics, when carefully laid plans are put to a crucial test. That’s where we are now with the arrival of the first major compliance dates under the regulations developed by FDA to implement the FDA Food Safety Modernization Act (FSMA). More information

FDA and Access to Medications

At the FDA, we understand how important it is for this treatment to be safe, effective, and work correctly every time. And in the case of a very severe reaction such as anaphylaxis, when there may be no second chance, the device that delivers the medication is just as critical. EpiPen, a popular form of emergency epinephrine that auto-injects the dose, is one of these treatments. But sometimes, when medications become prohibitively expensive, some people lose access to a potentially life-saving treatment. When that happens, people often look to the FDA. And so we are asked, what role does the FDA play? More information

FDA provides $21.8 million to states for FSMA produce safety rule implementation

FDA announced the awarding of a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

This guidance provides determinations for donors of HCT/Ps, with recommendations for testing living donors for West Nile Virus (WNV) using an FDA-licensed donor screening test. FDA believes that the use of an FDA-licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV from living donors of HCT/Ps and recommend that you use an FDA-licensed NAT to test living donors of HCT/Ps for evidence of infection with WNV as set forth in this guidance. More information

General Principles for Planning and Design of Multi-Regional Clinical Trials

With the increasing globalisation of drug development, it has become important that data 42 from multi-regional clinical trials (MRCTs) can be accepted by regulatory authorities 43 across regions and countries as the primary source of evidence to support marketing 44 approval of drugs (medicinal products). The purpose of this guideline is to describe 45 general principles for the planning and design of MRCTs with the aim of increasing the 46 acceptability of MRCTs in global regulatory submissions. More information

PRODUCT APPROVALS & CLEARANCES

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

FDA approved approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. More information

FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction

FDA approved permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. More information

FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness

FDA approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older. 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.

Safety Communication: Ovarian Cancer Screening Tests - FDA Recommends Against Use

FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. FDA believes that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer. More information

Recall: Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals - Superpotent and Subpotent Test Results

Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. More information

Recall: GlucaGen HypoKit by Novo Nordisk Inc - Detached Needles on Syringe

Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). A syringe with a detached needle cannot be used as prescribed. GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia in patients with diabetes who are treated with insulin. More information

Recall: Family Care Eye Wash by United Exchange Corp - Microbial Contamination

United Exchange Corp. is voluntarily recalling specific lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight threatening eye infection. More information

Recall: Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories- Microbial Contamination

United Exchange Corp. of Cerritos, CA is voluntarily recalling products due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection. 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.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (Sep 20-21)

The Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. The meeting will be open to the public. FDA is establishing a docket for public comment. More information

Pediatric Master Protocols Public Workshop (Sep 23)

This workshop will focus on pediatric master protocols. The workshop will provide a forum for discussion of the regulatory and scientific concerns of pediatric master protocols and clinical trial design considerations for these protocols. Additionally, applications of pediatric master protocols to specific therapeutic areas will be discussed. More information

Patient Focused Drug Development on Patients Who Have Received an Organ Transplant Public Meeting (Sep 27)

The purpose of this meeting is to obtain input on organ transplantation and current approaches to management of organ transplantation. FDA is committed to working with all stakeholders to develop safe and effective therapies for affected individuals. More information

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Workshop (Sep 29)

This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. More information

Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices (Sep 30)

A Public Workshop cosponsored by FDA, American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Association for Pediatric Ophthalmology and Strabismus (AAPOS), American Optometric Association (AOA), American Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens Association of Ophthalmologists, Inc. (CLAO). The purpose of the workshop is to discuss the increasing prevalence of myopia and to obtain consensus for clinical trial design attributes when contact lenses or other medical devices are studied for controlling the progression of myopia. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management (Oct 5)

The committees will be asked to discuss naloxone products intended for use in the community, specifically the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The committees will also be asked to discuss the criteria prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available. More information

DDI Webinar Series: FDA’s Bad Ad Program and other Innovative FDA Collaborations (Oct 6)

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeting the needs of all healthcare professionals and future clinicians. More information

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

The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season. Committee members will participate via teleconference. More information

Bone, Reproductive, and Urologic Drugs Advisory Committee Meeting (Oct 19)

The committee will discuss the efficacy and safety of new drug application (NDA) 201656 (desmopressin), 0.75 mcg/0.1 mL and 1.5 mcg/0.1 mL nasal spray, submitted by Serenity Pharmaceuticals, LLC, for the proposed treatment of adult onset nocturia. More information

Biosimilar User Fee Act Public Meeting (Oct 20)

The purpose of the meeting is to hear the public's views on the proposed recommendations for the reauthorization of BsUFA II. The following information is provided to help potential meeting participants better understand the history and evolution of the BsUFA program and the proposed BsUFA II recommendations. More information

Allergenic Products Advisory Committee Meeting (Oct 27)

The committee will hear updates of research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. 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

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