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  1. News & Events (Biologics)

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

Items related to biologics will be added to the top of the list as they are posted on the site.

Date Title
10/16/2019 BK190379 - DG Reader Net
10/16/2019 CBER Vacancy: Associate Director for Medical Policy – Title 38(F) Physician (GP-0602-15)
10/16/2019 Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance For Industry; Technical Specifications Document
10/16/2019 Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]
10/15/2019 October 15, 2019 Approval Letter - Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
10/15/2019 October 11, 2019 Approval Letter - Reagent Red Blood Cells - STN# 103898
10/15/2019 October 11, 2019 Approval Letter - DG Gel Cards - STN# 125449/55 et. al.
10/15/2019 October 11, 2019 Approval Letter - DG Gel 8 (Anti-Human Globulin) - STN# 125445/37
10/10/2019 Clinical Review STN 125251/244 - Wilate
10/10/2019 Statistical Review Memo STN 125251/244 - Wilate
10/10/2019 Clinical Pharmacology Supplement Review  STN 125251/244- Wilate
10/10/2019 Influenza candidate vaccine viruses improved by amino acid substitution in hemagglutinin
10/9/2019 Influenza Vaccine for the 2019-2020 Season
10/2/2019 Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
10/2/2019 CBER FY 2019 Recall Postings
10/2/2019 Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry
10/1/2019 Complete List of Currently Approved NDA and ANDA Application Submissions
10/1/2019 Complete List of Currently Approved Premarket Applications (PMAs)
10/1/2019 Complete List of Substantially Equivalent 510(k) Device Applications
10/1/2019 Complete List of Licensed Products and Establishments
10/1/2019 Biological Product Deviation Reporting - Blood Product Codes
10/1/2019 Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes
10/1/2019 Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
9/30/2019 Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)
9/30/2019 CBER-Regulated Products: Current Shortages
9/30/2019 Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry
9/27/2019 September 25, 2019 Approval Letter - Wilate
9/27/2019 eSubmitter Application History
9/26/2019 September 26, 2019 Approval Letter - Menveo
9/24/2019 September 24, 2019 Approval Letter- JYNNEOS
9/23/2019 Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry; Guidance for Industry
9/20/2019 Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Draft Guidance for Industry
9/19/2019 BK190361 - BloodRelay 1.0.0
9/19/2019 2019 Biological License Application Approvals
Update
9/19/2019 2019 Biological License Application Supplement Noteworthy Approvals
Update
9/19/2019 2019 Biological Device Application Approvals
Update
9/19/2019 September 18, 2019 Approval Letter - Flucelvax
9/17/2019 TCPro simulates immune system response to biotherapeutic drugs
9/16/2019 Expanded Access to Experimental Biologics


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