jueves, 14 de julio de 2016

FDA Updates for Health Professionals

ANNOUNCEMENTS

FDA Advisory Committee Members and ‘Appearance Issues’

FDA relies on its advisory committees as a source of independent scientific and technical expertise and advice on challenging public health issues. Most advisory committee members are appointed as “special government employees” (SGEs). Like regular government employees, these committee members are subject to Federal conflict of interest laws and regulations. More information

FDA Takes Action against Zika Virus

Zika virus was first identified in 1947 in Uganda and for decades only sporadic cases and a few outbreaks were recognized in a number of locations, including parts of Africa, Asia, and the Pacific. Since 2015, the situation has changed dramatically, with 48 countries and territories reporting a first outbreak of Zika virus as of July 2016. More information

Registration of Food Facilities: A Key Link in the Safety Chain

The FDA’s mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since last fall to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to take science- and risk-based actions to help prevent the contamination that leads to foodborne illness. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests

In support of the President’s Precision Medicine Initiative, FDA issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. More information

FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs

FDA issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The draft guidance documents apply to pharmacies, physicians, federal facilities, and outsourcing facilities. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first MRI-guided focused ultrasound device to treat essential tremor

FDA approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors. More information

FDA approves Differin Gel 0.1% for over-the-counter use to treat acne

FDA approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older. More information

FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens

FDA cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. More information

FDA approves first absorbable stent for coronary artery disease

FDA approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years. More information

FDA approves first HPV test for use with SurePath Preservative Fluid

FDA approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid. More information

FDA approves new medication for dry eye disease

FDA approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease. 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.

HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion

HeartWare Inc. is recalling the batteries because they may lose power prematurely due to faulty cells. If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death. More information

INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results

Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. More information

Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient

Dream Body Weight Loss is voluntarily recalling all lots of Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules to the consumer level. The Dream Body Extreme 800mg Gold, Dream Body 450mg and Dream Body Advanced 400mg have been found to contain sibutramine after FDA sampling and testing. 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.

Dermatologic and Ophthalmic Drugs Advisory Committee Meeting (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

CDER Small Business Regulatory Education for Industry (REdI) Pharmaceutical Quality Symposium (Jul 20 & 21)

CDER Small Business and Industry Assistance (SBIA) invites you to join us for this two-day in-depth exploration into the world of pharmaceutical quality. Interact with FDA’s subject matter experts from our Office of Pharmaceutical Quality (OPQ) as we address topics such as: More information

Cellular, Tissue, and Gene Therapies Advisory Committee Meeting (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

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Aug 4)

The committees will discuss new drug application (NDA) 208603, morphine sulfate extended-release tablets, submitted by Egalet U.S., Inc., with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties. The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse. More information

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (Aug 10)

The committee will discuss, make recommendations, and vote on information regarding a de novo request for the SEEKER Newborn Screening System (SEEKER System), by Baebies, Inc. The SEEKER System consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the SEEKER Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimens. More information

Pediatric Clinical Investigator Training; Public Workshop (Sep 12 & 13)

The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. More information

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee and the Pediatric Advisory Committee (Sep 15 & 16)

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation. 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