Updates Spotlight! Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Safe Tapering of Benzodiazepines (U01) Clinical Trials Not Allowed The FDA seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the safe tapering of benzodiazepines. Applicants must propose a comprehensive evidence-based plan that advances safe tapering of benzodiazepines. Cooperative Agreement to Support an Evidence-Based Clinical Practice Guideline for the Management of Postoperative Pain After Surgeries in Obstetric Patients (U01) Clinical Trials Not Allowed The FDA seeks applications to develop, disseminate, implement, and evaluate an evidence-based Clinical Practice Guideline (CPG) for the management of postoperative pain in obstetric patients who have undergone surgeries, including but not limited to cesarean delivery, vaginal delivery, and appendectomy during pregnancy. For both guidelines, the Letter of Intent Due Date is June 23, 2022 and the Application Due Date is August 3, 2022. Consumer Updates Mixing Medications and Dietary Supplements Can Endanger Your Health When you take prescription or over-the-counter (OTC) medications, do you also take a vitamin, mineral, or other dietary supplement? Have you considered whether there is any danger in mixing medications and dietary supplements? There could be. Certain dietary supplements can change absorption, metabolism, or excretion of a medication. If that happens, it can affect the potency of your medication, which means you may get either too much or too little of the medication you need. FDA 101: Dietary Supplements Multivitamins, vitamin D, echinacea, and fish oil are among the many dietary supplements lining store shelves or available online. Perhaps you already take a supplement or are thinking about using one. Dietary supplements can be beneficial to your health, but they can also involve health risks. So, it's important that you talk with a health care professional to help you decide if a supplement is right for you. Read on to learn what dietary supplements are (and are not), what role the FDA has in regulating them, and how to make sure you and your family use supplements safely. Got a Question About Your Pet's Health? Do you have questions about the drugs your veterinarian prescribes for your pet? Do you have questions about how and where to report a problem with an animal drug or pet food? If you're traveling with your pet—do you know where to get travel requirement information? The FDA's Center for Veterinary Medicine (CVM) regulates animal drugs and animal food (including pet food), conducts research that helps shape its regulatory activities. FDA Voices FDA's Center for Devices and Radiological Health's Continued Efforts to Return to Normal: Reopening for All Pre-Submissions By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH Since the beginning of the COVID-19 pandemic, the demand for medical devices has far exceeded anything we have seen in previous public health emergencies. The FDA's Center for Devices and Radiological Health (CDRH) has worked to address these unprecedented demands, while continuing to fulfill our mission to protect public health and facilitate medical device innovation. However, the significant increase in workload has adversely impacted our premarket review times for both COVID and non-COVID medical devices and our ability to meet all requests for pre-submission meetings. In April 2021 and December 2021, we communicated the steps we were taking to return our premarket program to normal operations. Today, we are providing our latest update. ICYMI! Supplement Your Knowledge: Dietary Supplement Education Initiative Dietary supplements can help people improve or maintain their overall health. But they may also come with health risks. Whether you're a consumer of dietary supplements or it's your job to inform and educate, it's important to know the facts before deciding to take any dietary supplement. Below, you'll find a wide range of downloadable educational resources about dietary supplements, including information about their benefits and risks, how they are regulated by the FDA, and much more. Webinars and Virtual Workshops Regulatory Education for Industry (REdI) Annual Conference 2022 June 6 - 10, 2022; 8:30 AM - 4:50 PM ET Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements, and also create awareness of current activities. The FDA will review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products such as vaccines, drugs, diagnostics, and personal protective equipment. Vaccines and Related Biological Products Advisory Committee June 7, 2022; 8:30 AM - 5:00 PM ET The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. 2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments June 7, 2022; 9:30 AM - 10:50 AM ET This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs were reauthorized as part of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) signed by the President on August 18, 2017. Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration June 7 - 9, 2022; 1:00 PM - 4:00 PM ET The purpose of the public workshop is to discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). The RSCP aims to build upon a foundation of strong partnerships to improve supply chain resiliency through proactive communication, collaboration, and engagement with patient advocates, health care providers, distributors, group purchasing organizations, manufacturers, as well as key component and material suppliers. Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement June 8, 2022; 9:30 AM - 5:15 PM ET The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione. The chart below identifies the use(s) FDA reviewed for each of the four bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances or another interested party will be invited to make a short presentation supporting the nomination. Registration is not required. Some Perspectives on Data Science and Coronaviruses June 9, 2022; 9:00 AM - 10:00 AM ET This lecture will present some perspectives, illustrated with recent COVID-19 experience and examples, on how in silico modelling and data science techniques could strengthen nonclinical (in vitro and animal) models for existing and emerging coronaviral diseases. Vaccines and Related Biological Products Advisory Committee June 14 - 15, 2022; 8:30 AM - 5:00 PM ET The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the following: On June 14, 2022, under Topic 1, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age. On June 15, 2022, under Topic II, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age. Registration is not required. Listening Sessions on FDA's Proposed Product Standards Prohibiting Menthol in Cigarettes and Characterizing Flavors in Cigars June 13 & 15, 2022; 10:00 AM - 4:00 PM ET The sessions are an opportunity for the public to verbally provide open public comment on the agency's proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and characterizing flavors (other than tobacco) in all cigars. Registration also includes a "listen-only" option for those who want to attend the sessions but do not want to request to speak. Use the below links to request to speak or register to attend. Note that you must register separately for each day. Speaking spots are limited, and we cannot guarantee we'll be able to accommodate all requests. We ask that groups and organizations select a single spokesperson to help us hear as many different perspectives as possible. While speaking spots are limited, listening spots are unlimited. Vaccines and Related Biological Products Advisory Committee June 28, 2022; 8:30 AM - 5:00 PM ET The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. Registration is not required. About Us The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. Did someone forward you this email? Sign up below! |
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