# food drug (blogs) — RSS Amplifier Recent posts from the 5 feeds in the RSS Amplifier directory that cover food drug. Page: Feed: --- ## [Cleared 510(k) Submissions with Supporting Documents - 2026](http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/cleared-510k-submissions-supporting-documents-2026) _2026-08-21 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Cleared 510(k) Submissions with Supporting Documents - 2026 ## [510(k) Blood Establishment Computer Software - 2026](http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/510k-blood-establishment-computer-software-2026) _2026-08-21 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Listing of 510(k) Blood Establishment Computer Software for the year 2026 ## [BK251307- Donor Information System Version 9.0](http://www.fda.gov/vaccines-blood-biologics/substantially-equivalent-510k-device-information/bk251307-donor-information-system-version-90) _2026-08-21 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Donor Information System (DIS) is used to manage donation center operations including but not limited to screening of donors for eligibility, immunizations, source plasma collection processing, and determining unit suitability. ## [Biologics Procedures (SOPPs)](http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-procedures-sopps) _2026-08-21 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates. ## [Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products](http://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products) _2026-08-20 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This is the guidance Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products ## [Potency Assessment of Active Immunotherapy Products](http://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assessment-active-immunotherapy-products) _2026-08-20 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This is the draft guidance Potency Assessment of Active Immunotherapy Products ## [eSubmitter Application History](http://www.fda.gov/industry/fda-esubmitter/esubmitter-application-history) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ History of all updates to the application software in reverse chronological order by version number ## [FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia](http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-patients-aged-8-years-and-older-glycogen-storage-disease-type-ia) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa) ## [Biologics Electronic Reading Room (eFOIA)](http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoia) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site. ## [ASCENIV](http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/asceniv) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Indicated for the treatment of Primary Immunodeficiency Diseases (PIDD) ## [AI QA That Opens Fix PRs (Sponsored)](https://crawlproof.com/a/0gkxljco3grn) _2026-08-19 · **Sponsored**_ Runs browser QA, files issues with repro evidence, and opens fix PRs. ## [Patient Listening Session Summaries](http://www.fda.gov/patients/fda-patient-listening-sessions/patient-listening-session-summaries) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. ## [FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device](http://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device) _2026-08-19 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. ## [ELEVIDYS](http://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/elevidys) _2026-08-19 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. ## [Biologics PREA Reviews and Labeling Changes](http://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-prea-reviews-and-labeling-changes) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ 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 ## [FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing - 09/29/2026](http://www.fda.gov/vaccines-blood-biologics/workshops-meetings-conferences-biologics/fda-roundtable-strengthening-supply-chain-blood-manufacturing-09292026) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ On September 29, 2026, the Food and Drug Administration’s, Center for Biologics Evaluation and Research, Office of Blood Research and Review is hosting a roundtable on strengthening the supply chain for the collection and manufacturing of Whole Blood and blood components for transfusion and further manufacturing, including Source Plasma. ## [Approved Cellular and Gene Therapy Products](http://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Listing of licensed and approved products from the Office of Therapeutic Products (OTP). ## [FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices](http://www.fda.gov/news-events/press-announcements/fda-seeks-public-feedback-inform-regulatory-approach-generative-ai-enabled-medical-devices) _2026-08-18 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics ## [EZPLAZ](http://www.fda.gov/vaccines-blood-biologics/blood-blood-products/ezplaz) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ Freeze Dried Plasma ## [OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023 - 04/25/2023](http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-gene-therapy-chemistry-manufacturing-and-controls-april-2023-04252023) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Tuesday, April 25, 2023. ## [OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 - 06/08/2023](http://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-cell-therapy-chemistry-manufacturing-and-controls-june-2023-06082023) _2026-08-18 · FDA · Whats New Vaccines Blood Biologics RSS Feed_ This event will focus on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP, and will be a continuation of the December 2022 virtual town hall. ## [Your 24/7 AI Media Buyer (Sponsored)](https://crawlproof.com/a/wKFOq5zG0Yld) _2026-08-18 · **Sponsored**_ Finds placement, geo, and funnel leaks and proposes fixes you approve ## [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) ## [Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals](https://www.federalregister.gov/documents/2026/08/17/2026-16716/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals) _2026-08-17 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. ## [Unlimited Mobile Internet, One V-SIM (Sponsored)](https://crawlproof.com/a/UvALEg0ERR1w) _2026-08-17 · **Sponsored**_ Automatically switches across T-Mobile, AT&T and Verizon; no throttling, no contract. ## [Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements](https://www.federalregister.gov/documents/2026/08/17/2026-16715/agency-information-collection-activities-proposed-collection-comment-request-investigational-new) _2026-08-17 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. ## [Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI](https://www.federalregister.gov/documents/2026/08/17/2026-16713/determination-of-regulatory-review-period-for-purposes-of-patent-extension-bizengri) _2026-08-17 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human… ## [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 ## [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. ## [FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drug-treat-new-world-screwworm-dogs-and-puppies) _2026-08-13 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs and puppies. ## [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 ## [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. ## [Key Efforts Required Alongside Regular Inspection to Make Dire Dawa Smoke-Free](https://www.efda.gov.et/key-efforts-required-alongside-regular-inspection-to-make-dire-dawa-smoke-free/) _2026-08-11 · EFDA · EFDA_ Key Efforts Required Alongside Regular Inspection to Make Dire Dawa Smoke-Free Dire Dawa, August 2026 — During a training session for tobacco control experts aimed at making Dire Dawa smoke-free, Abera Deneke, Executive officer of Public Relations and Communication at the Authority, stated that alongside the government’s regular tobacco control efforts, it is necessary to… ## [Substances Generally Recognized as Safe](https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe) _2026-08-11 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act). ## [Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI](https://www.federalregister.gov/documents/2026/08/10/2026-16247/determination-of-regulatory-review-period-for-purposes-of-patent-extension-brinsupri) _2026-08-10 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRINSUPRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human… ## [Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO](https://www.federalregister.gov/documents/2026/08/10/2026-16246/determination-of-regulatory-review-period-for-purposes-of-patent-extension-dayvigo) _2026-08-10 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAYVIGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human… ## [FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drug-prevent-new-world-screwworm-multiple-species-including) _2026-08-07 · FDA · FDA Press Releases RSS Feed_ FDA today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil topical suspension) wound spray for application on or around wounds for the prevention of New World screwworm (NWS) infestations (myiasis). ## [FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma](http://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma) _2026-08-06 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma.