| 9/28/2023 |
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Draft Guidance for Industry |
| 9/28/2023 |
CBER Cures Vacancy Announcement – Physician, AD-0602-Band C, Office of Therapeutic Products (OTP) |
| 9/28/2023 |
CBER Cures Vacancy Announcement - Lead Program Analyst, AD-0343-Band C, Office of Management (OM), Division of Acquisitions and Budget Resources (DABR), Budget Planning and Execution Branch (BPEB) |
| 9/27/2023 |
September 25, 2023 Clinical Memo - GLASSIA |
| 9/25/2023 |
September 22, 2023 Approval Letter - COMIRNATY |
| 9/22/2023 |
Voluntary Lot Withdrawal of Allergenic Extract – Pecan nut (Carya illinoinensis) – For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results |
| 9/21/2023 |
September 11, 2023 Clinical Review - SPIKEVAX |
| 9/21/2023 |
September 11, 2023 Statistical Review - SPIKEVAX |
| 9/21/2023 |
Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop |
| 9/21/2023 |
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry |
| 9/21/2023 |
User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act |
| 9/20/2023 |
September 11, 2023 Clinical Review Memo - COMIRNATY |
| 9/20/2023 |
Statistical Review - COMIRNATY |
| 9/20/2023 |
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards |
| 9/20/2023 |
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1); Draft Guidance for Industry |
| 9/19/2023 |
Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry |
| 9/18/2023 |
Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry |
| 9/15/2023 |
2023 Biological License Application Approvals
Updated through 8/31/2023 |
| 9/15/2023 |
2023 Biological Device Application Approvals
Updated through 8/31/2023 |
| 9/15/2023 |
Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry |
| 9/15/2023 |
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry |
| 9/14/2023 |
OTP Learn
Updated: Overview of Office of Therapeutic Products (OTP) Regulated Products video |
| 9/14/2023 |
Clinical Reviewer - ALBUMINEX |
| 9/14/2023 |
Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff |
| 9/14/2023 |
September 12, 2023 Summary Basis for Regulatory Action - ABRYSVO |
| 9/13/2023 |
Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
Updated: FDA will begin accepting requests to participate in year two of the CDRP on October 2, 2023. |
| 9/13/2023 |
September 11, 2023 Approval Letter - BIVIGAM |
| 9/13/2023 |
September 11, 2023 Approval Letter - ASCENIV |
| 9/11/2023 |
September 11, 2023 Approval Letter - SPIKEVAX |
| 9/11/2023 |
September 11, 2023 Approval Letter COMIRNATY |
| 9/11/2023 |
Warrior Families: Advancing Regenerative Medicine Through Science |
| 9/11/2023 |
CBER Vacancy: Staff Fellow/Visiting Associate – Parasitic Diseases |
| 9/11/2023 |
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for IRBs and Clinical Investigators |
| 9/11/2023 |
BK230961 - AQUIOS CL Flow Cytometer and AQUIOS Stem Kit |
| 9/8/2023 |
Center for Biologics Evaluation and Research Patient Engagement Program
Updated to include additional resources |
| 9/8/2023 |
OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products
Updated to include the event recording. |
| 9/7/2023 |
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff |
| 9/7/2023 |
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff |
| 9/7/2023 |
Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement |
| 9/6/2023 |
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry |
| 9/6/2023 |
Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks Linked to a Bone Matrix Product |
| 9/6/2023 |
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff |
| 9/6/2023 |
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff |
| 9/6/2023 |
Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff |
| 9/5/2023 |
Clinical Pharmacology Review - ATGAM |
| 9/1/2023 |
Complete List of Licensed Products and Establishments
Updated as of 8/31/2023 |
| 9/1/2023 |
Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 8/31/2023 |
| 9/1/2023 |
Complete List of Currently Approved Premarket Approvals (PMAs)
Updated as of 8/31/2023 |
| 9/1/2023 |
Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 8/31/2023 |
| 8/31/2023 |
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry |
| 8/30/2023 |
2023 PDA/ FDA Joint Regulatory Conference |
| 8/30/2023 |
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry |
| 8/30/2023 |
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry |
| 8/30/2023 |
CBER Cures Vacancy Announcement - Physician (Gastroenterology), AD-0602-Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE) |
| 8/29/2023 |
Vaccine Facts: Why you and your Family Need Vaccines |
