| 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Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry |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 |
| 5/12/2023 |
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Update |
| 5/12/2023 |
CBER-Regulated Products: Current Shortages
Update |
| 5/12/2023 |
May 11, 2023 Approval Letter - Adacel |
| 5/11/2023 |
DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products |
| 5/11/2023 |
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry |
| 5/11/2023 |
Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry |
| 5/11/2023 |
May 8, 2023 Approval Letter - HEPLISAV-B |
| 5/10/2023 |
May 9, 2023 Approval Letter - SPIKEVAX |
| 5/9/2023 |
Recombinant Protein-Based COVID-19 Vaccines Workshop
Updated with a recording of the event. |
| 5/9/2023 |
April 26, 2023 Summary Basis for Regulatory Action - VOWST |
| 5/9/2023 |
eSubmitter Application History
Update |
