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