miércoles, 1 de junio de 2016

FDA Updates for Health Professional

ANNOUNCEMENTS

FDA issues final food defense regulation

FDA finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply. More information

Artificial Pancreas: A Dialogue between the FDA and the Diabetes Community - June 2, 2016

On Thursday, June 2, 2016, the FDA will host a webinar to share general information about how the FDA regulates diabetes devices and ongoing efforts to accelerate the availability of artificial pancreas devices. The webinar will focus on current and emerging artificial pancreas technologies, and the FDA’s role in reviewing these technologies for safety and effectiveness. Representatives from the FDA and the Diabetes Patient Advocacy Coalition will be available to answer questions from webinar participants. More information

The Brave New World of Biosimilars

Medscape interview featuring Leah Christl, PhD, Associate Director, Therapeutic Biologics, FDA Center for Drug Evaluation and Research. More information

FDA modernizes Nutrition Facts label for packaged foods

FDA took a major step in making sure consumers have updated nutritional information for most packaged foods sold in the United States, that will help people make informed decisions about the foods they eat and feed their families. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Draft Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods

FDA issued a draft guidance for public comment that provides voluntary sodium reduction targets for the food industry.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

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

PRODUCT APPROVALS & CLEARANCES

FDA approves Ocaliva for rare, chronic liver disease

FDA granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.More information

FDA approves Zinbryta to treat multiple sclerosis

FDA approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.More information

FDA approves new diagnostic imaging agent to detect recurrent prostate cancer

FDA approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. More information

FDA approves first buprenorphine implant for treatment of opioid dependence

FDA approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program. 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.

Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk

Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature within battery that may cause a fire in the system monitor. The use of affected products may cause serious adverse health consequences, including death. More information

Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect

Hummingbird Med Devices Inc. is recalling the Hummi Micro-Draw Blood Transfer Device because the Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage. More information

Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death

FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug. 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.

FDA.Circulatory System Devices Panel of the Medical Devices Advisory Committee (Jun 2-3)

The committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. More information

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

The committees will be asked to discuss two new drug applications The committees will be asked to discuss whether the data submitted by the Applicants are sufficient to support labeling of the product with the properties expected to deter abuse. More information

Antimicrobial Drugs Advisory Committee (Jun 9)

The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence. More information

Over-the-Counter Monograph User Fees: Public Meeting (Jun 10)

FDA announced a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. FDA invites public comment on a potential OTC monograph user fee program and also invites suggestions regarding the features such a user fee program should include. More information

FDA-AACR: Oncology Dose Finding Workshop (Jun 13)

FDA, in co-sponsorship with the American Association for Cancer Research (AACR), is announcing a public workshop entitled “Oncology Dose Finding Workshop.” More information

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

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

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