10/3/2022 |
September 30, 2022 Approval Letter - PREVNAR 20 |
10/3/2022 |
FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products |
10/3/2022 |
Complete List of Licensed Products and Establishments |
10/3/2022 |
Complete List of Substantially Equivalent 510(k) Device Applications |
10/3/2022 |
Complete List of Currently Approved Premarket Approvals (PMAs) |
10/3/2022 |
Complete List of Currently Approved NDA and ANDA Application Submissions |
9/30/2022 |
Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes |
9/30/2022 |
Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes |
9/30/2022 |
Biological Product Deviation Reporting -- Blood Product Codes |
9/30/2022 |
BK220763 - LIFECODES LifeScreen XP |
9/29/2022 |
Natural History Studies to Support Regenerative Medicine: A How-To Webinar |
9/28/2022 |
Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs |
9/28/2022 |
Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff |
9/28/2022 |
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Guidance for Industry and Food and Drug Administration Staff |
9/28/2022 |
Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff |
9/26/2022 |
CBER Vacancy: Epidemiologist |
9/23/2022 |
Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff |
9/22/2022 |
OTAT Learn |
9/21/2022 |
FDA NanoDay Symposium 2022 |
9/20/2022 |
CBER Vacancy: Staff Fellow/Visiting Associate - Tick-Borne Diseases |
9/19/2022 |
September 16, 2022 Approval Letter - SKYSONA |
9/19/2022 |
September 16, 2022 Approval Letter - ERVEBO |
9/19/2022 |
Approval History, Letters, Reviews and Related Documents – ZYNTEGLO |
9/15/2022 |
OTAT Learn |
9/14/2022 |
2022 Biological License Application Approvals |
9/14/2022 |
2022 Biological Device Application Approvals |
9/14/2022 |
eSubmitter Application History |
9/13/2022 |
Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff |
9/13/2022 |
CBER Vacancy: Principal Investigator – Biologist/Research Pharmacologist |
9/12/2022 |
CBER Vacancy: Staff Fellow/Visiting Associate – Molecular Cell Biology |
9/12/2022 |
September 9, 2022 Approval Letter - RAGWITEK |
9/12/2022 |
September 9, 2022 Approval Letter - GRASTEK |
9/9/2022 |
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry |
9/9/2022 |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry |
9/9/2022 |
BK220750 - st’rim, macro st'rim, mini st’rim and nano st’rim |
9/8/2022 |
August 17, 2022 Summary Basis for Regulatory Action - ZYNTEGLO |
9/6/2022 |
CBER Vacancy: Principal Investigator - Biomedical Engineering |
9/2/2022 |
September 2, 2022 Approval Letter - JYNNEOS |
9/1/2022 |
Complete List of Licensed Products and Establishments |
9/1/2022 |
Complete List of Substantially Equivalent 510(k) Device Applications |
9/1/2022 |
Complete List of Currently Approved Premarket Approvals (PMAs) |
9/1/2022 |
Complete List of Currently Approved NDA and ANDA Application Submissions |
9/1/2022 |
BK210658 - IMUGARD® WB PLT Platelet Pooling Set |
8/31/2022 |
FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement |
8/29/2022 |
2022 Biological License Application Approvals |
8/29/2022 |
2022 Biological License Application Supplement Noteworthy Approvals |
8/29/2022 |
2022 Biological Device Application Approvals |
8/29/2022 |
August 25, 2022 Approval Letter - COMIRNATY |
8/29/2022 |
Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation |
8/22/2022 |
Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus |
8/22/2022 |
CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer |
8/19/2022 |
2022 Center for Biologics Evaluation and Research (CBER) Science Symposium |
8/18/2022 |
Key Facts About Vaccines to Prevent Monkeypox Disease |
8/17/2022 |
August 17, 2022 Approval Letter - ZYNTEGLO |
8/17/2022 |
Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement |
8/15/2022 |
PREA Non-Compliance Letters |