http://www.fda.gov/ en http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine Thu, 16 Dec 2021 14:30:54 EST FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine http://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-rhinosinusitis-nasal-polyps-developing-drugs-treatment Clinical / Medical Thu, 16 Dec 2021 11:12:44 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-rhinosinusitis-nasal-polyps-developing-drugs-treatment http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application. Thu, 16 Dec 2021 11:04:47 EST FDA http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances This page lists CMC and GMP Guidance documents. Thu, 16 Dec 2021 09:58:14 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances http://www.fda.gov/regulatory-information/search-fda-guidance-documents/inspection-injectable-products-visible-particulates Pharmaceutical Quality/CMC Thu, 16 Dec 2021 09:33:41 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/inspection-injectable-products-visible-particulates http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Thu, 16 Dec 2021 09:02:06 EST FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances This page contains a listing of Blood Guidances guidances. Wed, 15 Dec 2021 16:20:50 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8400-marketing-applications This is the SOPP Section 8400: Marketing Applications main page. Wed, 15 Dec 2021 14:57:18 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-procedures-sopps/section-8400-marketing-applications http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement This is the CBER Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement. Wed, 15 Dec 2021 14:07:18 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement http://www.fda.gov/regulatory-information/search-fda-guidance-documents/referencing-definition-device-federal-food-drug-and-cosmetic-act-guidance-regulatory-documents This guidance provides clarity on references to the terms “device” and “counterfeit device” – as well as references to section 201(h) of the FD&C Act. Wed, 15 Dec 2021 09:04:34 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/referencing-definition-device-federal-food-drug-and-cosmetic-act-guidance-regulatory-documents http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-14-2021 Coronavirus (COVID-19) Update: December 14, 2021 Wed, 15 Dec 2021 08:57:07 EST FDA http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-14-2021 http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee This is the Roster of the Vaccines and Related Biological Products Advisory Committee Wed, 15 Dec 2021 08:49:34 EST FDA http://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee http://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/roster-allergenic-products-advisory-committee As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees. Wed, 15 Dec 2021 08:49:28 EST FDA http://www.fda.gov/advisory-committees/allergenic-products-advisory-committee/roster-allergenic-products-advisory-committee http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR. Wed, 15 Dec 2021 07:54:44 EST FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda 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, 14 Dec 2021 17:48:17 EST FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-30-2021-meeting-announcement This is the CBER Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement. Tue, 14 Dec 2021 17:25:32 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-30-2021-meeting-announcement http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement This is the CBER Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement. Tue, 14 Dec 2021 17:15:14 EST FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Tue, 14 Dec 2021 16:34:26 EST FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines 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 Tue, 14 Dec 2021 16:05:18 EST FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances This page lists Clinical Guidance documents. Tue, 14 Dec 2021 15:39:26 EST FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/clinical-guidances