Whats New Vaccines Blood Biologics RSS Feed http://www.fda.gov/about-fda/contact-fda/stay-informed/rss-feeds/biologics/rss.xml en FDA’s Comprehensive Response to HIV — Part I http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fdas-comprehensive-response-hiv-part-i A multidisciplinary review and oversight program helps spur the development of effective treatments and approval of an expanding number of HIV drugs and drug combinations. FDA http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fdas-comprehensive-response-hiv-part-i Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays http://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN. FDA http://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays FDA Voices on Policy http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-voices-policy FDA Voices on Policy FDA http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-voices-policy FDA Voices: Perspectives From FDA Leadership and Experts http://www.fda.gov/news-events/fda-newsroom/fda-voices-perspectives-fda-leadership-and-experts Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement. FDA http://www.fda.gov/news-events/fda-newsroom/fda-voices-perspectives-fda-leadership-and-experts DENGVAXIA http://www.fda.gov/vaccines-blood-biologics/dengvaxia DENGVAXIA is Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. FDA http://www.fda.gov/vaccines-blood-biologics/dengvaxia Section 8400: Marketing Applications http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8400-marketing-applications This is the SOPP Section 8400: Marketing Applications main page. FDA http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8400-marketing-applications Safer Technologies Program for Medical Devices http://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices A new, voluntary program for medical devices that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics. FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices What’s New for Biologics http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Workshops, Meetings & Conferences (Biologics) http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-biologics Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties. FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-biologics FDA Voices on Medical Products http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-voices-medical-products FDA Voices on Medical Products FDA http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-voices-medical-products FDA Voices on Consumer Safety and Enforcement http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-voices-consumer-safety-and-enforcement FDA Voices on Consumer Safety and Enforcement FDA http://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-voices-consumer-safety-and-enforcement TCPro simulates immune system response to biotherapeutic drugs http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/tcpro-simulates-immune-system-response-biotherapeutic-drugs TCPro simulates immune system response to biotherapeutic drugs FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/tcpro-simulates-immune-system-response-biotherapeutic-drugs Innovation and Regulatory Science http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/innovation-and-regulatory-science Innovation and Regulatory Science FDA http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/innovation-and-regulatory-science MedWatch: The FDA Safety Information and Adverse Event Reporting Program http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program MedWatch home page FDA http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement - 09/13/2019 - 09/13/2019 http://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/allergenic-products-advisory-committee-september-13-2019-meeting-announcement-09132019-09132019 This is the main page for the Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement. FDA http://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/allergenic-products-advisory-committee-september-13-2019-meeting-announcement-09132019-09132019 Susan P. King-Harris, D.P.M. - 591682 - 09/09/2019 http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/susan-p-king-harris-dpm-591682-09092019 Bioresearch Monitoring Program/IRB FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/susan-p-king-harris-dpm-591682-09092019 Expanded Access to Experimental Biologics http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/expanded-access-experimental-biologics Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtai FDA http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/expanded-access-experimental-biologics Devices Guidances http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances This page lists Medical Device Guidance documents. FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances MCM-Related Guidance by Date http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-guidance-date Guidances and other information of special interest to MCM stakeholders, sponsors and applicants, listed by date FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-guidance-date Recently Issued Guidance Documents http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents