| 4/28/2023 |
April 28, 2023 Approval Letter - GARDASIL 9 |
| 4/28/2023 |
April 28, 2023 Approval Letter - TWINRIX |
| 4/28/2023 |
BK230824 - AMICUS Separator System |
| 4/28/2023 |
BK230806 - ImmuLINK (v3.0) |
| 4/28/2023 |
April 27, 2023 Approval Letter - PREVNAR 20 |
| 4/27/2023 |
Transcript - FDA CBER OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases
Main page: OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases |
| 4/27/2023 |
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
Update |
| 4/27/2023 |
eSubmitter Download and Installation |
| 4/26/2023 |
RDEA Pilot Program 2023 Public Workshop
Registration now open! |
| 4/26/2023 |
April 26, 2023 Approval Letter - VOWST |
| 4/26/2023 |
April 26, 2023 Approval Letter - BEXSERO |
| 4/25/2023 |
Regulatory Education for Industry (REdI) Annual Conference 2023 |
| 4/25/2023 |
OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 |
| 4/21/2023 |
CBER Cures Vacancy Announcement – Physician, AD-0602-Band C, Office of Therapeutic Products (OTP) |
| 4/21/2023 |
April 20, 2023 Approval Letter COMIRNATY |
| 4/20/2023 |
Clinical Trials: The Patient Experience
A recording is now available |
| 4/20/2023 |
Recombinant Protein-Based COVID-19 Vaccines Workshop |
| 4/19/2023 |
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Data as of March 31, 2023 |
| 4/19/2023 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
Data as of March 31, 2023 |
| 4/19/2023 |
CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
Data as of March 31, 2023 |
| 4/19/2023 |
April 14, 2023 Approval Letter - COAGADEX |
| 4/17/2023 |
April 17, 2023 Approval Letter -OMISIRGE |
| 4/17/2023 |
April 7, 2023 Approval Letter - HYQVIA |
| 4/14/2023 |
OTP Learn
New course: IND Decisions: Safe to Proceed, Clinical Hold, and Partial Hold |
| 4/13/2023 |
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers; Guidance for Industry |
| 4/13/2023 |
Clinical Investigator Status (Biologics)
Updated through 3/31/2023 |
| 4/13/2023 |
April 12, 2023 Approval Letter - VAXELIS |
| 4/10/2023 |
April 7, 2023 Approval Letter - AFLURIA |
| 4/10/2023 |
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders |
| 4/10/2023 |
Public Safety Notification on Amniotic Fluid Eyedrops |
| 4/07/2023 |
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff |
| 4/7/2023 |
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act; Draft Guidance for Industry |
| 4/7/2023 |
eSubmitter Application History
Update |
| 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 |
