Tuesday, September 30, 2025

September 30, 2025 at 05:47PM Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes

Use the following list of Biological Product Deviation (BPD) Codes to assign a specific code to a reportable event when you submit the report to FDA. Use the guidance document, "Biological Product Deviation Reporting for Blood and Plasma Establishments," (https://ift.tt/tl9MkuP) to determ

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September 26, 2025 at 07:41PM MedWatch: The 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.

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September 26, 2025 at 04:00PM MedWatch Forms for FDA Safety Reporting

Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online.

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Thursday, September 25, 2025

September 25, 2025 at 11:12PM ABECMA

ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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September 25, 2025 at 07:31PM MNEXSPIKE

MNEXSPIKE is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who are:
65 years of age and older, or
12 years through 64 years of age with

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September 25, 2025 at 04:17PM eSubmitter Application History

History of all updates to the application software in reverse chronological order by version number

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Wednesday, September 24, 2025

September 24, 2025 at 01:51PM Cellular & Gene Therapy Guidances

This page contains a listing of cellular and gene therapy guidances.

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Monday, September 22, 2025

September 23, 2025 at 01:10AM Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.

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September 23, 2025 at 01:08AM FDA use of Real-World Evidence in Regulatory Decision Making

The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.

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September 22, 2025 at 04:05PM 2025 Biological License Application Approvals

Listing of the 2025 Biological License Application Approvals

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September 22, 2025 at 02:40PM Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting - 09/24/2025

The Food and Drug Administration (FDA) is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment on 9/24/2025.

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September 19, 2025 at 01:50PM 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

This is the main page for the 2025 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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September 18, 2025 at 08:06PM Commissioner's National Priority Voucher (CNPV) Pilot Program

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.

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Tuesday, September 16, 2025

September 16, 2025 at 03:20PM NuVida Medical LLC - 707745 - 09/04/2025

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

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Thursday, September 11, 2025

September 11, 2025 at 10:15PM Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

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September 11, 2025 at 09:14PM CMC and GMP Guidances

This page lists CMC and GMP Guidance documents.

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September 11, 2025 at 02:31PM 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.

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Wednesday, September 10, 2025

September 10, 2025 at 08:47PM XYNTHA

XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.


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September 10, 2025 at 07:20PM Patient Listening Session Summaries

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.

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September 10, 2025 at 05:56PM 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

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September 10, 2025 at 03:29PM Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

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Monday, September 8, 2025

September 08, 2025 at 09:39PM Biosimilars Guidances

This page lists Biosimilars Guidance documents.

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