Vaccines, Blood & Biologics
Resources for You
SOPP 8506: Management of Shortages of CBER-Regulated Products
- FDA Draft Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (February 2012) (PDF - 226KB)
Food and Drug Administration Safety and Innovation Act (FDASIA) A Review of FDA's Approach to Medical Product Shortages Industry (Biologics) Healthcare Providers (Biologics) Consumers (Biologics)
- Return to the Office of Compliance and Biologics Quality (OCBQ) Page
CBER-Regulated Products: Shortages and Discontinuations
CBER-Regulated Products: Current Shortages
A tabular listing of current shortages of CBER-regulated products is provided on the page.
CBER-Regulated Products: Resolved Shortages
A tabular listing of resolved shortages of CBER-regulated products is provided on the page.
CBER-Regulated Products: Discontinuations
A tabular listing of discontinued CBER-regulated products is provided on the page.
Report a Shortage or Supply Issue to FDA
Contact information to report a shortage or supply issue to the appropriate Center is provided on the page.
- Federal Register Notice for Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Prosposed Rule
Strategic Plan for Preventing and Mitigating Drug Shortages(PDF - 381KB) A New Plan for Drug Shortages to Build on FDA’s Success FDA Acts to Prevent More Drug Shortages FDA takes two important actions on drug shortages
Recalls & Alerts
Approvals & Clearances
Complete List of Licensed Products and Establishments Complete List of Vaccines Licensed for Immunization and Distribution in the US Complete List of Currently Approved NDA and ANDA Application Submissions(PDF - 17KB) Complete List of Currently Approved Premarket Approvals (PMAs)(PDF - 15KB) Complete List of Substantially Equivalent 510(k) Device Applications(PDF - 243KB)