- CBER’s Manufacturers Assistance responds to general info requests from industry re: #CBER regulated products. Check out our webpage and take our survey!
- Influenza Virus Vaccine for the 2018-2019 Season
Updated: 8/2/2018 - Complete List of Licensed Products and Establishments
Posted: 8/2/2018; Updated as of 7/31/2018 - Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 110KB)
Posted: 8/2/2018; Updated as of 7/31/2018 - Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 113KB)
Posted: 8/2/2018; Updated as of 7/31/2018 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 1.7MB)
Posted: 8/2/2018; Updated as of 7/31/2018 - User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act (PDF - 474KB)
Updated: 8/2/2018
Headache Disorders in Pandemic Conditions
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