- OPPORTUNITIES FOR COMMENT / GUIDANCES
- PRODUCT APPROVALS & CLEARANCES
- PRODUCT SAFETY
- UPCOMING MEETINGS
Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients
Last week our nation lost a true pioneer in public health and consumer protection. Frances Oldham Kelsey, Ph.D., M.D., who joined FDA in 1960 as a medical officer, was known worldwide as a leader in drug safety and the protection of patients. She established that reputation in one of first FDA assignments: reviewing the marketing application for a drug called thalidomide, which was already available in dozens of countries around the world.
Advancing precision medicine by enabling a collaborative informatics community
FDA plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. Yet while more than 80 million genetic variants have been found in the human genome, we don’t understand the role that most of these variants play in health or disease. Achieving the President’s vision requires working collaboratively to ensure the accuracy of genetic tests in detecting and interpreting genetic variants. We are working towards that goal by developing an informatics community and supporting platform we call precisionFDA. More information
The Times They Are a Changin’ – And So is FDA
At a public meeting of the FDA Science Board, the agency is releasing our progress report, FDA Science Moving Forward, highlighting advances that FDA has made since the Science Board’s 2007 report FDA Science and Mission at Risk. Also at this meeting, a Science Board subcommittee will present its recommendations on FDA’s regulatory science programs, scientific workforce, and collaborations.
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.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels- Reopening of the Comment Period
FDA is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.
Medical Device Patient Labeling- Public Comments Requested
The CDRH Guidance on Medical Device Patient Labeling serves to assist manufacturers intheir development of patient labeling and to assist Center reviewers in their review and evaluation of the manufacturers' labeling. Medical device patient labeling includes any medical device information that is intended for a lay audience. It is intended to help assure that the device is used safely and effectively. This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices.
PRODUCT APPROVALS & CLEARANCES
FDA approves non-surgical temporary balloon device to treat obesity
FDA approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.
For more information on drug approvals or to view prescribing information and patient information, please visit
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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.
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion
FDA is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. FDA determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue.
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port
Baxter International Inc. announced a voluntarily recall of one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences.
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities
The FDA, the U.S. Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT), and Hospira are aware of cybersecurity vulnerabilities associated with the Symbiq Infusion System. FDA strongly encourages health care facilities transition to alternative infusion systems, and discontinue use of these pumps.
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.
Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing
FDA is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.
Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection
FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events
FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. FDA is also aware of bleeding complications related to both the Thoratec HeartMate II and HeartWare HVAD.
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
Cook Medical has received complaints that the catheter tip may split or separate from the catheter. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working. 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.
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.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Sep 10)
The committees will be asked to discuss new drug application (NDA) 206830, oxycodone immediate-release tablets, submitted by Purdue Pharma, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Sep 11)
The committees will discuss new drug application (NDA) 208090, oxycodone extended-release capsules for oral use, submitted by Collegium Pharmaceuticals, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate.
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.
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.
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.
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
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 firstname.lastname@example.org.
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.
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.
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.
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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