UpdatesSpotlight!
Food and Drug Administration Overdose Prevention FrameworkThe FDA Overdose Prevention Framework consists of four overarching priorities that align with the U.S. Department of Health & Human Services' Overdose Prevention Strategy to address the public health emergency as it continues to evolve. The overdose crisis is an evolving public health crisis; as such, FDA continues to evaluate our approach and make adjustments according to the latest available science and data.
Consumer Updates
Do You Need a Device That Claims to Clean a CPAP Machine?Most CPAP accessories such as hoses or tubes and masks can be cleaned with only mild soap and water. Follow your CPAP manufacturer's instructions. The FDA is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. We have answers to your questions related to this CPAP recall.
Spilling the Beans: How Much Caffeine is Too Much?According to medical experts, including here at the FDA, caffeine can be part of a healthy diet for most people, but too much of it can have negative effects and large amounts may pose a danger to your health. Depending on factors such as body weight, medications you may take, certain medical conditions, and individual sensitivity, “too much” can vary from person to person. Be aware of the level of caffeine in your diet and look out for signs when it’s too much.
Guidance DocumentsVoluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
FDA is issuing this guidance to help manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program, an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to FDA in a summary format on a quarterly basis. CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
This guidance document provides guidance on characteristics for consideration during the validation of the analytical procedures included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology
This guidance is complementary to GFI #63 (VICH GL1), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. The purpose of this document is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure included as part of a registration application for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. View all Official FDA Guidance Documents and other Regulatory Guidance
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!FDA In Your Day
Chief Medical Officer, Dr. Hilary Marston discusses Lyme disease.
Webinars and Virtual WorkshopsWebinar – Draft Guidance: Predetermined Change Control Plans for Medical Devices
September 3, 2024; 1 p.m. - 2:30 p.m. ET
FDA will host a webinar for industry and other interested stakeholders to answer questions about the draft guidance: Predetermined Change Control Plans for Medical Devices.
Registration is not necessary.
Please click the link to join the webinar. Passcode: b.0Acb FDA NIH: Regulatory Do's and Don'ts: Tips from FDA
September 4, 2024; 11 a.m. - 3 p.m. ET
The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics.
OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
September 5, 2024; 11 a.m. - 12:30 p.m. ET
FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall. In this event, experts from OTP’s Office of Cellular Therapy and Human Tissue CMC will answer questions regarding development and readiness of chemistry, manufacturing, and controls (CMC) data and information for late-stage investigational new drug applications (INDs) – INDs intended to collect primary evidence of effectiveness to support a marketing application for cell therapy and tissue-engineered products.
ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
September 6, 2024; 9 a.m. - 5 p.m. ET
FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI) is convening this one-day workshop to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate and other topics.
National Hispanic/Latino Family Cancer Awareness. An Oncology Center of Excellence Project Community Initiative #LatinoCancer
September 20, 2024; 11 a.m. - 12 p.m. ET
The FDA's Oncology Center of Excellence Project Community will hold the inaugural National Hispanic/Latino Family Cancer Awareness Week on September 20-26, 2024. The week will feature a Conversation on Cancer public panel discussion on September 20, and a social media campaign throughout the week using the hashtag #LatinoCancer.
Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases
September 20, 2024; 11 a.m. - 4:30 p.m. ET
The FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting and opening a docket to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases.
Virtual Patient Engagement Advisory Committee Meeting Announcement on Patient-Centered Informed Consent in Clinical Study
October 30, 2024; 10 a.m. - 5 p.m. ET
The FDA is announcing a virtual Patient Engagement Advisory Committee (the Committee) meeting on Patient-Centered Informed Consent in Clinical Study. The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.
If you have questions about this virtual public meeting, contact Letise Williams.
View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts About UsThe 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. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov. | 
August 30, 2024
