| 4/6/2023 |
Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop
Updated with workshop recordings |
| 4/6/2023 |
April 3, 2023 Untitled Letter - Fidia Pharma USA Inc. |
| 4/5/2023 |
BK230804 - Elecsys HIV Duo |
| 4/3/2023 |
March 30, 2023 Untitled Letter - Minneapolis Regenerative Medicine |
| 4/3/2023 |
Identification of Medicinal Products — Implementation and Use; Guidance for Industry |
| 4/3/2023 |
Complete List of Licensed Products and Establishments
Updated as of 3/31/2023 |
| 4/3/2023 |
Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 3/31/2023 |
| 4/3/2023 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 3/31/2023 |
| 4/3/2023 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 3/31/2023 |
| 3/29/2023 |
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff |
| 3/23/2023 |
Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
Updated |
| 3/23/2023 |
Electronic Systems, Electronic Records, and Electronic Signatures Webinar |
| 3/23/2023 |
Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation - Workshop Agenda |
| 3/23/2023 |
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
Updated - March 23, 2023 |
| 3/22/2023 |
Annual Summary for Fiscal Year 2022
Biological Product Deviation Reports Annual Summaries page |
| 3/21/2023 |
2023 Biological License Application Approvals
Updated through 2/28/2023 |
| 3/21/2023 |
2023 Biological License Application Supplement Noteworthy Approvals
Updated through 2/28/2023 |
| 3/21/2023 |
2023 Biological Device Application Approvals
Updated through 2/28/2023 |
| 3/20/2023 |
eSubmitter Application History |
| 3/20/2023 |
Pharmacogenomic Data Submissions; Draft Guidance for Industry |
| 3/20/2023 |
Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Devices at the Point of Care To Produce a Therapeutic Article |
| 3/20/2023 |
CBER-Regulated Products: Permanent Discontinuations |
| 3/17/2023 |
March 16, 2023 Approval Letter - JYNNEOS |
| 3/17/2023 |
February 21, 2023 Summary Basis for Regulatory Action - ALTUVIIIO |
| 3/16/2023 |
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Guidance for Industry |
| 3/15/2023 |
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry |
| 3/15/2023 |
March 14, 2023 Approval Letter - JYNNEOS |
| 3/14/2023 |
FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop Agenda
Office of Therapeutic Products Advanced Manufacturing and Analytical Technologies for Regenerative Medicine Therapies Workshop page. |
| 3/13/2023 |
Investigational COVID-19 Convalescent Plasma; Guidance for Industry |
| 3/13/2023 |
Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry |
| 3/13/2023 |
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry |
| 3/13/2023 |
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry |
| 3/8/2023 |
eSubmitter Application History |
| 3/08/2023 |
February 27, 2023 Clinical Review Memo - VARIVAX |
| 3/08/2023 |
Statistical Review - VARIVAX |
| 3/08/2023 |
February 27, 2023 Clinical Review Memo - Measles, Mumps, and Rubella Virus Vaccine Live |
| 3/08/2023 |
Statistical Review - Measles, Mumps, and Rubella Virus Vaccine Live |
| 3/7/2023 |
February 27, 2023 Clinical Review - ProQuad |
| 3/7/2023 |
February 27, 2023 Statistical Review - ProQuad |
| 3/7/2023 |
CBER Vacancy: Staff Fellow/Visiting Associate - Interdisciplinary Scientist |
| 3/7/2023 |
OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023 |
