Friday, December 30, 2022

December 30, 2022 at 05:02PM FY 2019 Report from the Director

Fiscal Year 2019 was an exciting time at CBER, as we continued to conduct important mission-oriented research and approved important new products that protect and improve public health. These included a novel gene therapy, vaccines, treatments for immune deficiencies, and tests for protection of the

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Thursday, December 22, 2022

December 22, 2022 at 07:49PM REBINYN

Product approval information is indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. for use in adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management of bleeding.

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December 21, 2022 at 08:55PM 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.

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Wednesday, December 21, 2022

December 21, 2022 at 10:31PM Roster of the Blood Products Advisory Committee

This is the Roster of the Blood Products Advisory Committee (BPAC).

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Tuesday, December 20, 2022

December 20, 2022 at 09:06PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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December 20, 2022 at 03:50PM Office of Digital Transformation’s New Focus on Technology Leadership

The LMAP lays out our plans to strengthen our technology leadership capabilities to effectively drive change at the business, technology, data, and cybersecurity levels.

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Monday, December 19, 2022

December 19, 2022 at 08:44PM Know Your Treatment Options for COVID-19

Patients today have more treatment options in the battle against coronavirus disease. FDA has approved two drug treatments for COVID-19 and authorized others for emergency use during this public health emergency.

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December 19, 2022 at 02:55PM TENIVAC

TENIVAC is a product approval Indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.

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December 16, 2022 at 06:04PM Meeting Materials, Vaccines and Related Biological Products Advisory Committee

These are the Meeting Materials for the Vaccines and Related Biological Products Advisory Committee

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Thursday, December 15, 2022

December 15, 2022 at 08:49PM Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

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December 15, 2022 at 06:12PM 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.

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Wednesday, December 14, 2022

December 14, 2022 at 08:14PM 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.

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December 13, 2022 at 08:40PM Drugs@FDA Data Files

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

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December 13, 2022 at 06:10PM Consumer Updates

Science-based health and safety information you can trust.

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Friday, December 9, 2022

December 09, 2022 at 10:30PM Vaccines

CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.

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December 09, 2022 at 10:30PM Blood & Blood Products

CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. FDA has strengthened the safeguards that protect patients from unsuitable blood and blood products and has increased its oversight of the blood industry.

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December 09, 2022 at 10:14PM Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

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Thursday, December 1, 2022

December 01, 2022 at 11:18PM FDALabel: Full-Text Search of Drug Product Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

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December 01, 2022 at 06:06PM 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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December 01, 2022 at 05:17PM BR220737 - SeCore CDx HLA Sequencing System

The SeCoreTM CDx HLA Sequencing System, a prescription device under 21 CFR Part 801.109

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