What’s New for Biologics | FDA

What’s New for Biologics | FDA

Complete List of Currently Approved NDA and ANDA Application Submissions

Posted: 10/1/2019

Complete List of Currently Approved Premarket Applications (PMAs)

Posted: 10/1/2019

Complete List of Substantially Equivalent 510(k) Device Applications

Posted: 10/1/2019

Complete List of Licensed Products and Establishments

Posted: 10/1/2019

Biological Product Deviation Reporting - Blood Product Codes

Posted: 10/1/2019

Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes

Posted: 10/1/2019

Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes

Posted: 10/1/2019

10/2/2019	CBER FY 2019 Recall Postings
10/2/2019	Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry
10/1/2019	Complete List of Currently Approved NDA and ANDA Application Submissions
10/1/2019	Complete List of Currently Approved Premarket Applications (PMAs)
10/1/2019	Complete List of Substantially Equivalent 510(k) Device Applications
10/1/2019	Complete List of Licensed Products and Establishments
10/1/2019	Biological Product Deviation Reporting - Blood Product Codes
10/1/2019	Biological Product Deviation Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes
10/1/2019	Biological Product Deviation Reporting and HCT/P Deviation Reporting - Deviation Codes
9/30/2019	Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)