http://www.fda.gov/ en http://www.fda.gov/news-events/fda-voices/using-whole-governments-approach-combating-illicit-health-products A whole-of-governments approach is the best way to protect the public health from the trade of illicit health products and the FDA will advocate for that approach. Thu, 01 Sep 2022 12:08:37 EDT FDA http://www.fda.gov/news-events/fda-voices/using-whole-governments-approach-combating-illicit-health-products http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Thu, 01 Sep 2022 11:40:23 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/bk180180-arthrex-angel-system-kit This is the main page for the CBER 510k BK180180: Arthrex Angel System Kit. Wed, 31 Aug 2022 16:02:01 EDT FDA http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/bk180180-arthrex-angel-system-kit http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccine-boosters Updated COVID-19 vaccine boosters are designed to give you broad protection against COVID-19, including better protection against the Omicron variant. Wed, 31 Aug 2022 15:53:17 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccine-boosters http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. Wed, 31 Aug 2022 14:32:37 EDT FDA http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use 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. Wed, 31 Aug 2022 11:55:13 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines 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. Wed, 31 Aug 2022 10:48:28 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-biologics http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data Expanded Access (Compassionate Use) Submission Data Wed, 31 Aug 2022 10:09:31 EDT FDA http://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data 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, 31 Aug 2022 09:55:59 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, 31 Aug 2022 09:52:10 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines http://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/towards-longer-acting-factor-viii-products-better-purity A description of Andrey Sarafanov's research program and related publications. Tue, 30 Aug 2022 16:41:07 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/towards-longer-acting-factor-viii-products-better-purity http://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/evaluating-host-and-microbial-factors-impact-efficacy-polysaccharide-vaccines A description of Mustafa Akkoyunlu's research program and related publications. Tue, 30 Aug 2022 16:33:33 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/evaluating-host-and-microbial-factors-impact-efficacy-polysaccharide-vaccines http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances This page lists CMC and GMP Guidance documents. Tue, 30 Aug 2022 16:22:37 EDT FDA http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances 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, 30 Aug 2022 14:40:26 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/california-ivf-fertility-center-598552-08092021 Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Tue, 30 Aug 2022 14:39:53 EDT FDA http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/california-ivf-fertility-center-598552-08092021 http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/bk170114-asi-automated-rpr-test-syphilis-use-asi-evolution This is the main page for the 510K BK170114: ASI Automated RPR test for Syphilis for use on the ASI Evolution. Tue, 30 Aug 2022 13:52:02 EDT FDA http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/bk170114-asi-automated-rpr-test-syphilis-use-asi-evolution http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-pertaining-additional-safety-protections-regarding-use-fecal-microbiota-transplantation On June 13, 2019, the Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). Bacterial infections caused by multi-drug resistant organisms (MDROs) have Tue, 30 Aug 2022 11:08:20 EDT FDA http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-pertaining-additional-safety-protections-regarding-use-fecal-microbiota-transplantation http://www.fda.gov/vaccines-blood-biologics/comirnaty Vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) in individuals 16 years of age and older. Mon, 29 Aug 2022 09:13:56 EDT FDA http://www.fda.gov/vaccines-blood-biologics/comirnaty http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted Novavax COVID-19 Vaccine Fri, 26 Aug 2022 12:49:21 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted 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. Fri, 26 Aug 2022 08:26:04 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance-information-fda