Updates ICYMI!  Request for advisory committee nominations: consumer organizations and individuals FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. For advisory committee vacancies listed in this notice, and those that may occur through December 31, 2023: - Consumer organizations: Consumer organizations interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email (to ACOMSSubmissions@fda.hhs.gov) stating that interest to FDA by August 15, 2022.
- Consumer representatives: Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups. Consumer representative nominations should be submitted electronically through the FDA Advisory Committee Membership Nomination Portal, by August 15, 2022.
FDA Authorizes Revisions to Evusheld (tixagevimab co-packaged with cilgavimab) Dosing The FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval. Shelf-Life Extension of Evusheld under Emergency Use Authorization The Assistant Secretary for Preparedness and Response (ASPR) and FDA announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Do Not Use Baby Neck Floats Due to the Risk of Death or Injury The FDA is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury. Guidance Documents - Request for Comment Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics This guidance provides recommendations to assist industry in the development of oligonucleotide therapeutics under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314. Specifically, this guidance represents the FDA's recommendations for certain evaluations including pharmacokinetic, pharmacodynamic, and safety assessments during oligonucleotide therapeutic development. FDA Issues Draft Guidance on Patient Focused Drug Development The FDA issued a draft guidance, "Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments." This guidance (Guidance 3) is the third in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. When final, this guidance will represent the current thinking of FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health on this topic. Consumer Updates Generic Drugs Undergo Rigorous FDA Review  Maybe you've had this experience: You go to fill a prescription, and the pharmacist mentions there is a generic available. You've noticed generic drugs often cost less and wonder: How can I be sure they are as safe and effective as brand name drugs? Applying the rigorous standards set out by law, the FDA ensures that generic drugs are as safe and effective as the brand name drug products they copy. Today, about 9 in 10 prescriptions filled in the U.S. are for generic drugs. Webinars and Virtual Workshops Patient Engagement Advisory Committee Meeting Announcement July 12 - 13, 2022 Day 1: 10:00 AM - 4:00 PM ET
Day 2: 10:00 AM - 2:00 PM ET The FDA announces a forthcoming public advisory committee meeting of the CDRH Patient Engagement Advisory Committee. The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public. Registration is not required. OMDRHO 2022 Annual Virtual Conference July 13, 2022; 9:00 AM - 5:30 PM This conference provides a unique opportunity for industry and OMDRHO to discuss and collaborate on current topics related to advancing public health.  One Health at FDA: From Concept to Application July 14, 2022; 12:00 PM - 1:00 PM ET The One Health concept works at the interconnection of three domains: human, animal, and environmental health. One Health presents a more holistic view of the FDA mission. The FDA's efforts to improve health go beyond recognizing disease transmission through an isolated lens of human health and acknowledge human-animal interactions and associated environmental factors. Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis July 25, 2022; 11:00 AM - 1:00 PM ET Speakers and participants will discuss a range of issues data collection and analysis, focusing on lessons learned and on areas identified as particularly challenging for stakeholders. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents. 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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