Postmarketing Adverse Event Reporting – Required Information
Companies are required to submit certain information to the agency for postmarketing adverse events. See the links below for examples of these requirements:
Prescription drugs (brand and generic)
- Companies with approved new drug applications
- Companies with approved abbreviated new drug applications
- Manufacturers, packers and distributors named on the approved prescription drug labels (NDA)
- Manufacturers, packers and distributors named on the approved generic drug labels (ANDA)
- Manufacturers, packers and distributors named on unapproved prescription drug labels
Therapeutic biologics
- Companies with approved applications for therapeutic biologics (BLA)
- Manufacturers, packers, distributors or certain other participants involved in manufacturing named on the approved therapeutic biologic labels (BLA)
Over-the-counter drugs
- Companies with approved new drug applications (NDA)
- Companies with approved abbreviated new drug applications (ANDA)
- Manufacturers, packers and distributors named on the approved over-the-counter drug labels (NDA)
- Manufacturers, packers and distributors named on the approved over-the-counter drug labels (ANDA)
- Manufacturers, packers and distributors named on unapproved over-the-counter drug labels
- Retailers named on unapproved over-the-counter drug labels
Combination products