http://www.fda.gov/ en http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-28-march-1-2023-meeting This is the main landing page for the Vaccines and Related Biological Products Advisory Committee February 28 - March 1, 2023 Meeting Announcement and meeting materials. Fri, 31 Mar 2023 17:23:31 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-28-march-1-2023-meeting http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-7-2023-meeting-announcement This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting Announcement and meeting materials. Fri, 31 Mar 2023 17:19:35 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-7-2023-meeting-announcement http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted Novavax COVID-19 Vaccine Fri, 31 Mar 2023 16:17:42 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted http://www.fda.gov/vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance. Fri, 31 Mar 2023 16:08:02 EDT FDA http://www.fda.gov/vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics http://www.fda.gov/news-events/fda-voices/national-minority-health-month-better-health-through-better-understanding As the FDA observes National Minority Health Month this April, we are highlighting the Enhance Equity Initiative and our work to raise awareness on the importance of improving the health of racial and ethnic minority populations and reducing health disparities. Fri, 31 Mar 2023 09:53:34 EDT FDA http://www.fda.gov/news-events/fda-voices/national-minority-health-month-better-health-through-better-understanding http://www.fda.gov/news-events/fda-newsroom/fda-voices Insights from FDA leadership and experts into the agency's work on policy, consumer safety & enforcement, medical products, food, & tobacco. Thu, 30 Mar 2023 15:47:32 EDT FDA http://www.fda.gov/news-events/fda-newsroom/fda-voices http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal-product-development The purpose of this guidance is to provide a framework for considering whether and what type of 59 long-term neurologic, sensory and developmental evaluations could be useful to support a 60 determination of safety of a drug, biological product, or device. Thu, 30 Mar 2023 14:23:44 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-long-term-clinical-neurodevelopmental-safety-studies-neonatal-product-development http://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial Marketing Submission Recommendations for Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions Thu, 30 Mar 2023 08:49:44 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial http://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions Patient Listening Sessions led by FDA’s Office of Patient Affairs provide an opportunity for medical product Centers to engage with patients, caregivers, and advocates about their experiences and perspectives. Wed, 29 Mar 2023 15:41:24 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson Wed, 29 Mar 2023 14:59:21 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines Information about Spikevax, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized. Wed, 29 Mar 2023 14:53:42 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines Information about the Comirnaty, Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated COVID-19 vaccine boosters are now FDA-authorized. Wed, 29 Mar 2023 14:44:39 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/guidance-and-other-information-special-interest-mcm-stakeholders Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases Wed, 29 Mar 2023 14:40:13 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/guidance-and-other-information-special-interest-mcm-stakeholders http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances This page lists Medical Device Guidance documents. Wed, 29 Mar 2023 11:55:39 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Wed, 29 Mar 2023 11:55:10 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Wed, 29 Mar 2023 11:54:36 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section This guidance describes FDA's RTA policy for premarket submissions submitted for cyber devices before October 1, 2023. Wed, 29 Mar 2023 09:02:17 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more. Tue, 28 Mar 2023 16:54:03 EDT FDA http://www.fda.gov/consumers/consumer-updates/vaccines-blood-biologics http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Tue, 28 Mar 2023 16:49:53 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) Tue, 28 Mar 2023 14:54:45 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files