April 22, 2015

ANNOUNCEMENTS

FDA's Keynote Address to the Annual Conference of the Food and Drug Law Institute

We do our best when we go where the science leads us, and base our decisions on thorough, data-driven analyses. This assures our work will benefit patients and consumers. If we cut corners with the science, ultimately patients and consumers are shortchanged. There will be no change with Peggy’s departure regarding this central role of science-based decision making during my watch.Let me now turn to FDA’s accomplishments since this meeting was held a year ago. I can’t cover all of them because if I did I’d be talking all day and into the night. Instead I’ll simply cover some highlights. More information

24th Annual U.S. Public Health Service Nursing Recognition Day Webinar

You are invited to celebrate Nurses Day 2015 with the United States Public Health Service. The 24th Annual Nurse Recognition Day is going virtual, and for the first time we will host the entire event from a computer, so come and celebrate what nurses have accomplished this past year!

Event: Ethical and Quality Care – A Nursing Standard

When: Wednesday May 6, 2015

Time: 11:00 a.m. (EDT) to 2:00 p.m. (EDT)

This is a free online event that will offer Continuing Education Units after successfully completing a post test. More information

FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme

FDA is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury. Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids and is sold on the Internet and in some retail stores and gyms. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century

FDA is seeking broad public input on the current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health. FDA has developed a list of questions to facilitate a more productive discussion at the public hearing. This list is not intended to be exclusive, and FDA encourages comments on other matters related to the development and regulation of drug and biological products labeled as homeopathic. Submit comments by 6/22/2015. More information

Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs

Guidance for Industry

This draft guidance pertains to submissions of promotional materials for human prescription drugs to the FDA made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant. Specifically, this draft guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research(CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER), and explains certain aspects of electronic submission of promotional materials.More information

Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products

This notice solicits comments on Sun Protection Factor (SPF) labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products. Submit comments by 06/15/2015. More information

Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions Guidance

The Food and Drug Administration is introducing a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needsfor life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMAs) or de novo requests. More information

Balancing Premarket and Postmarket Data Collectionfor Devices Subject to Premarket Approval Guidance for Industry and Food and Drug Administration Staff

This guidance clarifies the Food and Drug Administration’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs). More specifically, this guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support premarket approval while still meeting the statutory standard of reasonable assurance of safety and effectiveness. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first-of-its-kind corneal implant to improve near vision in certain patients

FDA approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery. More information

FDA approved the Gastric Emptying Breath Test (GEBT)

The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (gastroparesis). Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine when muscles in the stomach are not contracting properly. It is often the result of intestinal surgery, neurological diseases such as Parkinson's disease and multiple sclerosis, or high blood glucose levels due to diabetes. More information

FDA approves first generic Copaxone to treat multiple sclerosis

FDA approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection. More information

FDA approves Corlanor to treat heart failure

FDA approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate. More information

FDA has approved the Impella 2.5 System

The Impella 2.5 System includes a mini heart pump mounted at the end of a thin, flexible tube (catheter), a console that drives the pump, and an infusion pump that flushes the pump. The heart pump can be implanted in the left side of the heart without open chest surgery to help pump blood in patients who need short-term support. 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.

Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication

FDA is alerting pet owners, veterinarians, health care providers and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing the nonsteroidal anti-inflammatory drug (NSAID) flurbiprofen. People using these medications should use care when applying them in a household with pets, as even very small amounts could be dangerous to these animals. More information

VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub

These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage. More information

MedWatch March 2015 Safety Labeling Changes

This posting includes 67 products with safety labeling changes to the following sections:BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE. 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.

The 2015 Office of Regulatory Science and Innovation Science Symposium (Apr 27)

The purpose of the public workshop is to increase scientific collaborations with government institutions, academia, industry and other stakeholders, working to improve science, training, and networking in accordance with the FDA mission of the advancement of regulatory science. This venue will also enhance knowledge and awareness of the FDA ORSI resources and provide guidance of its available services. More information

Patient-Focused Drug Development Meeting on Chagas Disease (Apr 28)

FDA is conducting a public meeting on Chagas Disease Patient-Focused Drug Development. FDA is interested in obtaining patient input on the impact of chagas disease on daily life and patients’ views on currently available therapies to treat the condition. More information

Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee (Apr 29)

The committees will discuss talimogene laherparepvec, Amgen, Inc., BLA 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma.More information

Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee (Apr 30- May 1)

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. More information

Patient Focused Drug Development for Functional Gastrointestinal Disorder (May 11)

The FDA is holding a public meeting and an opportunity for public comment on Patient-Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. More information

The committee will meet in open session to discuss the development and licensure of Ebola vaccines.More information

Pulmonary-Allergy Drugs Advisory Committee (May 12)

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. More information

Blood Products Advisory Committee (May 13)

The committee will meet in open session to discuss strategies for implementation of serological and nucleic acid testing for Babesia microtiin blood donors. In the afternoon, the committee will hear update presentations on the following topics: 1) FDA considerations for Hemoglobin S Testing in blood donors; and 2) FDA considerations for a revised blood donor deferral policy for men who have sex with men. Following the update presentations, the committee will hear presentations on the research programs of the Laboratory of Cellular Hematology, Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. More information

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee (May 14-15)

The committee will discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States. More information

Food and Drug Administration Science Forum 2015; Public Workshop (May 27-28)

The purpose of the public workshop is to highlight science conducted at the FDA by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The focus of the forum will be the eight FDA Regulatory Science priority areas. 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