# guidance documents — RSS Amplifier Recent posts from the 1 feeds in the RSS Amplifier directory that cover guidance documents. Page: Feed: --- ## [Regulatory Harmonization and Convergence](http://www.fda.gov/vaccines-blood-biologics/international-activities/regulatory-harmonization-and-convergence) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Agency engages in a range of explicit harmonization initiatives, a subset of which includes the participation of CBER. ## [Exporting CBER-Regulated Products](http://www.fda.gov/vaccines-blood-biologics/compliance-actions-biologics/exporting-cber-regulated-products) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved CBER-regulated products. ## [Tissue Establishment Registration](http://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Also, provided information on when to register update regist ## [Blood Establishment Registration and Product Listing](http://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/blood-establishment-registration-and-product-listing) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65 ## [Collaborations and Partnerships](http://www.fda.gov/vaccines-blood-biologics/science-research-biologics/collaborations-and-partnerships) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ CBER Research Collaborations and Partnerships ## [Vaccine Adverse Event Reporting System (VAERS) Questions and Answers](http://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-questions-and-answers) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ VAERS is a national vaccine safety surveillance program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). ## [Vaccine Adverse Events](http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/vaccine-adverse-events) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Information about the Vaccine Adverse Event Reporting System (VAERS), which is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to detect possible signals of adverse events associated with v ## [CYFENDUS](http://www.fda.gov/vaccines-blood-biologics/vaccines/cyfendus) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ For use as a post-exposure prophylactic vaccine following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial regimen. ## [Drugs@FDA Data Files](http://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files) _2026-08-17 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) ## [Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting](http://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/human-cell-tissue-products-hctp-adverse-reaction-reporting) _2026-08-14 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting ## [Prime Noise-Cancelling Picks (Sponsored)](https://crawlproof.com/a/KavL73hUpuK8) _2026-08-14 · **Sponsored**_ Browse Prime-eligible, 4-star-and-up noise-cancelling earbuds with fast shipping and deals ## [What’s New for Biologics](http://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics) _2026-08-14 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Latest news from the Center for Biologics Evaluation and Research ## [BioThrax](http://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ BioThrax is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. ## [Commissioner's National Priority Voucher (CNPV) Pilot Program](http://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months. ## [Phase 1 Investigational New Drug (IND) Navigator](http://www.fda.gov/industry/phase-1-investigational-new-drug-ind-navigator) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an successful Investigational New Drug (IND) application. ## [FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development](http://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials. ## [CMC and GMP Guidances](http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/cmc-and-gmp-guidances) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists CMC and GMP Guidance documents. ## [Recently Issued Guidance Documents](http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists Recently Issued CBER and Cross-Center Guidance Documents. ## [Labeling for CBER-Regulated Products](http://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/labeling-cber-regulated-products) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Labeling for CBER-Regulated Products ## [Laboratory Information Bulletins](http://www.fda.gov/science-research/field-science-and-laboratories/laboratory-information-bulletins) _2026-08-13 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Laboratory Information Bulletins available to the public ## [Sync bookmarks across every browser (Sponsored)](https://crawlproof.com/a/kasdSmz5wZi9) _2026-08-13 · **Sponsored**_ Two-way sync across Chrome, Firefox and Safari; built-in ad and tracker blocker. ## [Administrative Guidances](http://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/administrative-guidances) _2026-08-12 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This page lists Administrative Guidance documents.