http://www.fda.gov/ en http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Mon, 01 May 2023 17:10:11 EDT FDA http://www.fda.gov/consumers/consumer-updates http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccines Information about Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccine boosters are now FDA-authorized for all doses. Mon, 01 May 2023 17:04:32 EDT FDA http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccines http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccines Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older. Mon, 01 May 2023 17:04:08 EDT FDA http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccines http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/janssen-covid-19-vaccine Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson Mon, 01 May 2023 17:03:41 EDT FDA http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/janssen-covid-19-vaccine http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted Novavax COVID-19 Vaccine, Adjuvanted Mon, 01 May 2023 17:03:21 EDT FDA http://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics. Mon, 01 May 2023 16:05:13 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/jobs-center-biologics-evaluation-and-research-cber http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics Latest news from the Center for Biologics Evaluation and Research Mon, 01 May 2023 13:20:41 EDT FDA http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines Information about Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccine boosters are now FDA-authorized for all doses. Mon, 01 May 2023 08:38:10 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/medical-countermeasure-monitoring-and-assessment FDA guidance and regulatory information, specific FDA projects related to monitoring and assessment of MCMs, ongoing FDA work related to medical product assessment in general, and key efforts relevant to MCM monitoring and assessment outside of FDA Fri, 28 Apr 2023 17:06:41 EDT FDA http://www.fda.gov/emergency-preparedness-and-response/mcm-issues/medical-countermeasure-monitoring-and-assessment 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. Fri, 28 Apr 2023 16:29:58 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/vaccines/gardasil-9 Product approval information for Human Papillomavirus 9-valent Vaccine, Recombinant also known as Gardasil 9. Fri, 28 Apr 2023 16:17:09 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9 http://www.fda.gov/vaccines-blood-biologics/vaccines/twinrix Active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. Fri, 28 Apr 2023 15:55:29 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/twinrix http://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-may-12-2023-meeting-announcement-05122023 This is the main landing page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) May 12, 2023 Meeting Announcement and meeting materials. Fri, 28 Apr 2023 15:14:09 EDT FDA http://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-may-12-2023-meeting-announcement-05122023 http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. Fri, 28 Apr 2023 11:44:38 EDT FDA http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. Fri, 28 Apr 2023 10:56:03 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries http://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides FDA approves Vowst, the first orally administered fecal microbiota product. Vowst is approved for the prevention of recurrence of Clostridioides difficile infection in individuals 18 years of age and older, following completion of antibacterial treatment for recurrent CDI. Fri, 28 Apr 2023 08:59:09 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides http://www.fda.gov/regulatory-information/search-fda-guidance-documents/s12-nonclinical-biodistribution-considerations-gene-therapy-products ICH - Safety Fri, 28 Apr 2023 08:45:05 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/s12-nonclinical-biodistribution-considerations-gene-therapy-products http://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20 Indication: Active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F,14, 15B, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. Thu, 27 Apr 2023 16:39:14 EDT FDA http://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20 http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otat-town-hall-clinical-development-gene-therapy-products-rare-diseases-02072023 The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to the clinical development of gene therapy products for rare diseases (excluding hematology/oncology products). Thu, 27 Apr 2023 15:53:53 EDT FDA http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otat-town-hall-clinical-development-gene-therapy-products-rare-diseases-02072023 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. Thu, 27 Apr 2023 13:43:10 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions