jueves, 16 de julio de 2015

FDA Updates for Health Professionals

ANNOUNCEMENTS

Celebrating the 3rd Anniversary of the FDA Safety and Innovation Act

The landmark Food and Drug Administration Safety and Innovation Act (FDASIA) gives FDA authority to speed patient access to safe and effective products, increase stakeholder involvement in FDA processes, and enhance the safety of the drug supply chain. Just as important, FDASIA improves the agency’s ability to help prevent drug shortages. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Acute Ischemic Stroke Medical Devices Trials Workshop; Public Workshop; Request for Comments

Acute ischemic stroke medical devices are intended to remove blood clots from the cerebral neurovasculature by mechanical, laser, ultrasound, or a combination of technologies. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for acute ischemic stroke emerging technologies and help to speed development and approval of future submissions. The public workshop will be held on October 6, 2015, from 1 p.m. to 5:30 p.m. More information

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance describes FDA's intent to address the safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin United States Pharmacopeia (USP) monographs as well as outline safety testing recommendations. This draft guidance is not final nor is it in effect at this time. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 7, 2015. More information

Medical Device User Fee Amendments; Request for Comments

FDA invites public comment on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program. More information

Prescription Drug User Fee Act; Request for Comments

FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2018-2022. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

FDA approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with certain EGFR mutations. It is intended for the treatment of patients whose tumors express the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations). The therascreen EGFR RGQ PCR Kit was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa. More information

FDA approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder

The effectiveness of Rexulti in treating schizophrenia was evaluated in 1,310 participants in two 6-week clinical trials. Rexulti was shown to reduce the occurrence of symptoms of schizophrenia compared to placebo. More information

FDA approves new drug to treat heart failure

FDA approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure. More information

FDA approves new treatment for cystic fibrosis

FDA approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation. Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) is now approved to treat cystic fibrosis (CF) in patients 12 years and older, who have the F508del mutation, which causes the production of an abnormal protein that disrupts how water and chloride are transported in the body. Having two copies of this mutation (one inherited from each parent) is the leading cause of CF. 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.

Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion. In June 2015, Mylan Institutional issued a second notification of the market withdrawal. Some units of this drug may still be on the market. Please check your inventory and crash boxes, quarantine and discontinue distribution and use of affected lots. More information

June 2015 Safety Labeling Changes

Pharmacists in the Office of Health and Constituent Affairs reviewed June 2015 labeling changes to inform you of 30 products with safety revisions to prescribing information. More information

Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events

FDA identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat Suture Delivery Device and/or its associated devices. These reports describe 6 patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery. More information

Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. More information

Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage

Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. More information

FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation

May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately. 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.

Science Board to the Food and Drug Administration; Notice of Meeting (Jul 29)

The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. The Board will hear an overview of two scientific activities from the Center for Veterinary Medicine and will be asked to provide input on strategies to implement targeted directives contained in the National Strategy for Combating Antibiotic-Resistant Bacteria, designed to guide action by public health, health care, and veterinary partners in a common effort to address urgent and serious drug-resistant threats that affect people in the United States and around the world. 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

Biomarkers of Tobacco Exposure: A Public Workshop (Aug 3-4)

This workshop is designed to open the discussion on how to identify and implement the use of biomarkers for the purpose of tobacco product regulation, including product reviews and rules development. The purpose of the workshop is to gather information on identifying potential biomarkers that may be currently appropriate for regulatory use as well as identify biomarkers for which more data is required, but may be implemented for use in the near future. Further, the workshop is a forum for discussing a framework for developing a scientifically robust and transparent process for biomarker selection, establishing appropriate evidentiary standards or criteria for utilization by the FDA, and identifying areas of research which may help move the field forward. 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