The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
December 16, 2024
Dear Colleague,
The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated.
FDA’s Role In Managing Drug Shortages | FDA In Your Day Ep. 18
You may have heard about drug shortages in the news, or from a family member or friend. While the FDA can't eliminate drug shortages on our own, we can help lessen their impact on patient care.
Skip the Antibacterial Soap; Use Plain Soap and Water
When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected? According to the FDA currently there isn’t sufficient evidence to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water.
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
ICYMI!
Patient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is a joint project between the FDA and the Clinical Trials Transformation Initiative (CTTI). The PEC is an ongoing, shared setting in which the patient community (PEC members), FDA, and CTTI discuss many topics for improving communication, education, and patient engagement related to medical product regulation.
Join us for an engaging discussion that will bring together key stakeholders in the fight against cervical cancer, including representatives from the patient advocacy community, academia, community oncology, the EMA and the FDA to discuss the historical path that has led us to the current treatment landscape, the impact of new therapies on individuals with cervical cancer and their families, areas of ongoing high impact research, and what the future might bring.
This guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more artificial intelligence-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. FY25 FDA BAA Question and Answer Session will provide an opportunity to the applicants to learn more about the application process. Join us to learn more about the FY25 BAA application process, next steps, and clarify any questions on how to apply.
The purpose of this workshop is to provide a multidisciplinary forum to examine the existing information and evidence surrounding DPD deficiency testing, hear about the current clinical approaches to DPD deficiency testing from practicing oncology healthcare providers, and discuss future directions for advancing the field.
The FDA Biosimilar User Fee Act (BsUFA) III Regulatory Science Pilot program is hosting its second virtual event. The agenda includes a recap of the activities of regulatory science pilot program from the last engagement that occurred on October 16, 2023. Additionally, the webinar will include a status update on the programs current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. Lastly, FDA staff will present the next steps planned for the BsUFA III regulatory science program.
Day 1; Tue, Jan 28; 8:30 a.m. - 4 p.m. ET Day 2; Wed, Jan 29; 8:30 a.m. - 4 p.m. ET
FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. KASA is designed to capture and manage knowledge during the lifecycle of a drug product; establish rules and algorithms to facilitate risk identification, mitigation, and communication; perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities; and provide a structured assessment that minimizes text-based narratives and summarization of information provided in applications.
The Committees will discuss the findings of the completed ER/LA OA PMRs 3033-1 and 3033-2 (link to Release and Reissue letter: https://www.fda.gov/media/95546/download).
These PMRs are prospective (3033-1) and retrospective (3033-2) epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics for management of chronic pain, including patients prescribed ER/LA OAs.
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
About Us
The Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA.
December 16, 2024
