6/14/2023 |
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry |
6/13/23 |
June 9, 2023 Clinical Review - AFSTYLA |
6/13/23 |
June 9, 2023 Statistical Review - AFSTYLA |
6/13/2023 |
CBER Cures Vacancy Announcement - Physician, AD-0602-Band C, Office of Vaccines Research and Review (OVRR), Division of Vaccines and Related Product Applications (DVRPA) |
6/13/2023 |
CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Oncology Branch 2 (OB2) |
6/13/2023 |
CBER Vacancy: Principal Investigator: Molecular Biologist with Bioinformatics experience |
6/13/2023 |
BK220668 - VorFat System |
6/12/2023 |
June 9, 2023 Approval Letter - AFSTYLA |
6/12/2023 |
June 9, 2023 Approval Letter - FEIBA |
6/12/2023 |
June 9, 2023 Approval Letter - MenQuadfi |
6/9/2023 |
Virtual Meeting June 20, 2023: Decentralized Clinical Trials (DCT) Draft Guidance |
6/9/2023 |
FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers - June 20, 2023 |
6/09/2023 |
Summary Basis for Regulatory Action - VYJUVEK |
6/07/2023 |
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff |
6/7/2023 |
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Guidance for Industry |
6/02/2023 |
April 27, 2023 Clinical Review - Prevnar20 |
6/02/2023 |
April 27, 2023 Statistical Review - Prevnar20 |
6/02/2023 |
Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry |
6/2/2023 |
Complete List of Licensed Products and Establishments
Updated as of 5/31/2023 |
6/2/2023 |
Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 5/31/2023 |
6/2/2023 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 5/31/2023 |
6/2/2023 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 5/31/2023 |
6/1/2023 |
May 31, 2023 Approval Letter - ABRYSVO |
6/1/2023 |
CBER Vacancy: Staff Fellow/Visiting Associate – Molecular Virologist |
5/30/2023 |
May 26, 2023 Approval Letter - Reagent Red Blood |
5/26/2023 |
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry |
5/26/2023 |
Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop
Recordings now available |
5/26/2023 |
Study Data Technical Conformance Guide - Technical Specifications Document; Guidance for Industry |
5/25/2023 |
May 3, 2023 Summary Basis for Regulatory Action - AREXVY |
5/25/2023 |
May 25, 2023 Approval Letter - VAXNEUVANCE |
5/25/2023 |
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry |
5/25/2023 |
May 1, 2023 Clinical Review Memo - ATGAM |
5/24/2023 |
May 22, 2023 Untitled Letter - AT Venture Center for Global Techtrepreneurship, LLC dba Regenerelle, LLC |
5/23/2023 |
May 22, 2023 Approval Letter - SHINGRIX |
5/22/2023 |
CBER Cures Vacancy Announcement – Clinical Pharmacologist Reviewer, AD-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH), Benign Hematology Branch (BHB) |
5/19/2023 |
May 19, 2023 Approval Letter - VYJUVEK |
5/19/2023 |
CBER Cures Vacancy Announcement - Branch Chief, AD-0602-Band D, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE) |
5/18/2023 |
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry |
5/17/2023 |
April 7, 2023 Statistical Review Memo - HYQVIA |
5/17/2023 |
April 7, 2023 Clinical Review Memo - HYQVIA |
5/17/2023 |
BK230807 - Adaptive Autologous Processing System |
5/17/2023 |
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act; Draft Guidance for Industry |
5/15/2023 |
BK220779 - Capture Positive Control Cell |