jueves, 12 de diciembre de 2019

What’s New for Biologics | FDA

What’s New for Biologics | FDA

What’s New for Biologics

Posted: 12/11/2019




12/11/2019December 10, 2019 - Approval Letter - Anti-D (RH1) IgM/IgG 125621/2
12/11/2019December 10, 2019 Approval Letter - DG Gel 8 Anti-IgG (Rabbit), DG Gel Cards - STN# 125445/32
12/11/2019CBER Vacancy: Postdoctoral Fellow/Visiting Associate – Viral Vaccines (Biologist), RG-0401
12/9/2019Complete List of Licensed Products and Establishments
12/9/2019Complete List of Substantially Equivalent 510(k) Device Applications
12/9/2019Complete List of Currently Approved Premarket Approvals (PMAs)
12/9/2019Complete List of Currently Approved NDA and ANDA Application Submissions
12/9/2019December 6, 2019 Approval Letter - TENIVAC
12/9/2019BK190333 - Terumo Operational Medical Equipment Software (TOMEs), Version 7.1
12/9/2019CBER-Regulated Products: Current Shortages
12/6/2019Public Safety Notification on Exosome Products
12/5/2019December 3, 2019 Approval Letter - Panoscreen EXTEND
12/5/2019User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
12/5/2019Influenza Vaccine for the 2019-2020 Season
12/5/2019Job Vacancy Announcement: Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602)
12/4/2019December 3, 2019 Approval Letter - Data-Cyte Plus 2, and Data-Cyte Extend  0.8 % Reagent Red Blood Cells
12/4/2019BK190389 - ALBAcheck BGS Monoclonal Control
12/3/2019November 25, 2019 Untitled Letter - Chara Biologics, Inc.
12/3/2019Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
12/2/2019March 3, 2020 Workshop - Facilitating End-to-End Development of Individualized Therapeutics
11/29/2019November 26, 2019 Approval Letter - Pneumovax 23
11/27/2019November 25, 2019 Order to Cease Manufacturing - Gynecology, Reproductive Endocrinology and Fertility Institute (GREFI)
11/27/2019Influenza Vaccine for the 2019-2020 Season
11/25/2019FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions
11/22/2019November 20, 2019 Untitled Letter - RichSource Stem Cells, Inc.
11/21/2019Influenza Vaccine for the 2019-2020 Season
11/18/20192019 Biological Device Application Approvals
11/18/20192019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
11/18/2019November 7, 2019 - Anti-Fyb (Murine Monoclonal) (Recombinant)
11/18/2019November 7, 2019 - Anti-Fya (Murine Monoclonal) (Recombinant)
11/15/2019SOPP 8116: Use of Electronic Signatures for Regulatory Documents
11/14/2019Influenza Vaccine for the 2019-2020 Season
11/13/2019November 12, 2019 Approval Letter - Rotarix
11/13/2019CBER-Regulated Products: Current Shortages
11/12/2019BK190349 - RD2 System

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