Dear Colleague,
FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.
Public health and safety is the highest priority at the FDA. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two million adverse event reports submitted every year to the FDA Adverse Event Reporting System (FAERS) through the MedWatch Program and to the Vaccine Adverse Event Reporting System (VAERS) by patients, family members, and health care providers, as well as adverse event reports submitted by regulated industry. [11/06/2019]
The FDA authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S. “The ability to rationally select treatments for patients about to start or already taking antiviral therapy provides another tool in our ongoing fight against HIV” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research." [11/05/2019]
Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, the FDA has been investigating the detection of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, commonly known by the brand name Zantac. [11/01/2019]
Consumer Update
Pacemakers, insulin pumps and other medical devices are becoming more advanced. Most contain software and connect to the internet, hospital networks, your mobile phone, or other devices to share information. So, it is important to make sure medical devices are cyber secure.
New technologies are being applied to all different types of devices—those that are implantable or wearable, or used at home or in health care settings. The advances can offer care that is safer, timelier and more convenient. [11/06/2019]
Safety Information
The FDA is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events. [11/05/2019]
“Even though the Essure device is no longer sold in the U.S., the FDA is committed to continuing to monitor the postmarket safety of the device for women who have the device implanted. Today, we are providing an update on our ongoing postmarket activities related to Essure, so that patients and health care professionals have up-to-date information on this device,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is also reminding health care professionals and facilities that before the end of this year, all Essure devices that have not been implanted should be returned to Bayer. We remain committed to collecting long-term safety information and ensuring that Bayer continues to meet its mandated postmarket study obligations beyond 2019. We’ll continue to communicate with patients and health care professionals about Essure as new information becomes available.” [11/04/2019]
Public Meetings/Workshops
Date: November 21, 2019
Time: 12:00 PM - 1:00 PM ET
Agenda: To hear about ongoing and planned patient engagement initiatives currently underway at the FDA, and the anticipated impact of these efforts on patients and clinical research
Date: December 10, 2019
Time: 9:00 AM ET
Location: Washington Marriott at Metro Center; 775 12th St NW, Washington, DC 20005
Agenda: This public meeting will explore the state of the science of clinical research evaluating medication adherence involving FDA-regulated products.
You may register here
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