July 29, 2015

ANNOUNCEMENTS

FDA revises proposed Nutrition Facts label rule to include a daily value for added sugars

FDA proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families. The percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories. More information

Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs

At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., and patients in this country will have earlier access to innovation. More information

More Collaboration, Research Needed to Develop

The U.S. Food and Drug Administration’s drug approval process—the final stage of drug development—is the fastest in the world, which means Americans typically have first access to new drugs when they are demonstrated to be safe and effective. But even as our agency has transformed the approval process—approving 51 new molecular entities and biological products last year alone, including more new orphan drugs for rare diseases than in any previous year—drug discovery and development is not keeping pace for many diseases. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Request for Quality Metrics - Guidance for Industry

This guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry. More information

Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry

Provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support your analytical methodologies. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves new treatment for chronic hepatitis C genotype 3 infections

The FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. More information

FDA approves Praluent to treat certain patients with high cholesterol

The FDA approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. More information

FDA approves new treatment for most common form of advanced skin cancer

The U.S. Food and Drug Administration today approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. Odomzo works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers. By suppressing this pathway, Odomzo may stop or reduce the growth of cancerous lesions. More information

FDA approves Technivie for treatment of chronic hepatitis C genotype 4

The FDA approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis). Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection. More information

FDA approves diagnostic test to differentiate between types of HIV infection

The FDA approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens. Two major types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been identified in the United States. HIV-1 and HIV-2 are similar, but distinct viruses. More information

FDA authorizes use of prosthesis for rehabilitation of above-the-knee amputations

The FDA authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device instead uses fixtures and screws implanted into the patient’s remaining thigh bone to connect an external prosthetic limb. 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.

Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter

Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. More information

Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use

FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects. More information

Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance

Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance.The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. More information

0.9 % Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter

Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The matter was identified prior to patient administration and there have been no adverse events associated with this issue reported to Baxter. More information

Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns

FDA is warning that a serious lung condition called pulmonary hypertension, which is high pressure in the blood vessels leading to the lungs, has been reported in infants and newborns treated with Proglycem (diazoxide) for low blood sugar. In all cases, the pulmonary hypertension resolved or improved after Proglycem was stopped. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the Proglycem prescribing information. More information

Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models

UPDATED recall classified by FDA as Class I. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead. Required actions for customers added- Quarantine and discontinue use of the affected devices, Return affected product using the instructions in the Recall Notice. 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.

Quality Metrics Public Meeting (Aug 24)

The public meeting and draft guidance are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the authority of section 704 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance includes an explanation of CDER and CBER approaches to collecting and using data to aid in ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and that they support continuous improvement and innovation in the pharmaceutical manufacturing industry. More information

2015 PDA/FDA Joint Regulatory Conference (Sep 28 - 30)

"Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions". Practical solutions and advice for solving some of the current issues facing today’s pharmaceutical industry.More information

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting (Sep 24)

The committee will discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization. The system, originally approved in November 2002, under P020014, consists of a delivery system and nickel-containing permanent implants. The implants are placed without a skin incision, through the vagina, within each fallopian tube; they elicit tissue in growth, which over time results in tubal occlusion. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System. The committee will be asked to evaluate currently available scientific data pertaining to the safety and effectiveness of the Essure System, such as events related to implant perforation/migration, device removal, chronic pain, allergic reactions, and unintended pregnancy. More Information

Vaccines and Related Biological Products Advisory Committee Meeting Announcement (Sep 15)

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. More information

Public Workshop - Medical Device Patient Labeling (Sep 29-30)

The FDA is announcing a public workshop entitled “Medical Device Patient Labeling”. The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health is seeking input about these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental agencies. More information

Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments (Oct 5-6)

The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, the scientific community, the pharmaceutical industry, public health agencies, patients, patient advocates, health care system administrators, prescribers, dispensers, hospitals, infusion centers, health informatics experts, third-party payers, distributors, and the general public concerning the impact of REMS on the health care delivery system, including the impact on patients and health care providers. The discussion will focus on strategies for characterizing and evaluating the impact of REMS on the health care delivery system and on patient access to drugs subject to REMS.More information

Public Workshop - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use (Oct 16)

FDA is announcing a Public Workshop entitled “Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.” The purpose of this workshop is to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. More information

RESOURCES

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

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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.

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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.

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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.

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