sábado, 18 de junio de 2016

FDA Updates for Health Professionals

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FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

FDA finalized its efforts to streamline the process used by physicians to requestexpanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition. More information

Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Tobacco? Tell FDA 

FDA wants to hear from you—and has updated the online toolyou can use to report a problem. The Department of Health and Human Services’ Safety Reporting Portal (SRP) provides a standardized way for consumers, health care professionals, manufacturers, and clinical investigators to let FDA know about an unexpected health or safety issue with a tobacco product.More information.

FDA To Hold Webinar on Guidance for Voluntarily Reducing Sodium

FDA) will host a webinar on Tuesday, June 21, 2016, to review our draft guidance that provides voluntary sodium reduction targets for the food industry. FDA issued the guidance on June 1, 2016. Registration is not required. More information


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Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act

These guidance documents explain FDA’s policy regarding the conditions under which the agency does not intend to take action against state-licensed pharmacies, federal facilities, and licensed physicians (under section 503A) or outsourcing facilities (under section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections. More information  

Use of Symbols in Labeling

FDA  is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. More information

Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition Draft Guidance: Dissemination of Patient-Specific Information from Devices by Device Manufacturers 

The purpose of this guidance is to clarify that that FDA requirements do not prohibit manufacturers from sharing patient-specific information recorded, stored, processed, retrieved and/or derived from a medical device with the patient who is either treated or diagnosed with that device.  We hope that clarification of this policy will help patients receive access to accurate, usable information from medical devices so that they can be more engaged with their healthcare providers in making sound medical decisions.    More information

Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period

FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016. More information

Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods

FDA issued a  draft guidance for public comment that provides voluntary sodium reduction targets for the food industry. The draft short-term (2-year) targets seek to decrease sodium intake to about 3,000 mg per day. The long-term (10-year) targets seek to reduce sodium intake to 2,300 milligrams per day. The targets, which cover nearly 150 food categories, are intended to complement many existing efforts by food manufacturers, restaurants and food service operations to reduce sodium in foods.More information

FDA’s final guidance: “Postmarket Surveillance Under Section 522 of the Federal Food, Drug & Cosmetic Act” 

Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance of certain class II or class III devices.  This guidance document clarifies the 522 postmarket surveillance process and provides manufacturers with information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions. More information

Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition 

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses. More information

Use of Electronic Health Record Data in Clinical Investigations; Draft Guidance for Industry

The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance aims to facilitate use of electronic health record (EHR) data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation. More information

Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers

FDA is issuing this draft guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance characteristics of Infectious Disease Next Generation Sequencing Based Diagnostic Device for Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers (hereafter referred to as “Infectious Disease NGS Dx devices”). Infectious Disease NGS Dx devices are for use as aids in the diagnosis (identification) of microbial infection and in selecting appropriate therapies. More information 


FDA Approved

FDA approves vaccine to prevent cholera for travelers

FDA approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera. More information

FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

 approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC). More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA orDailyMed


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Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. More information 

Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. More information

Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk

The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. More information 

Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk

Pharmavite LLC is recalling specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. More information  

Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars

FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch.  Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. . More information


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.
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Blood Products Advisory Committee (Jun 20)

The Committee members will participate in the meeting via teleconference. In open session, the Committee will discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research. More information

Pharmacy Compounding Advisory Committee Advisory Committee Meeting Announcement (Jun 23)

The committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access. More information

Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Jun 28)

The committee will discuss supplemental new drug application (sNDA) 204629 for empagliflozin (JARDIANCE) tablets and sNDA 206111 for empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. More information

Arthritis Advisory Committee Meeting Announcement (Jul 13)

The committee will discuss biologics license application 761042, for GP2015, a proposed biosimilar to Amgen Inc.’s ENBREL (etanercept) submitted by Sandoz, Inc. More information

Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement (Jul 19)

The committee will discuss biologics license application (BLA) 761032, brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. More information

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (Jul 21 -22)

On July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.’s, Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM) device . On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere Afinion™ HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS.  The proposed intended use, as stated by the sponsor: More information

Cellular, Tissue, and Gene Therapies Advisory Committee Meeting Announcement (Jul 26)

On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA. More information 


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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.govComunicaciones 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
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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 patientsafety.  More information

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