What’s New for Biologics

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