REMS Program
REMS Program. Shall mean the Risk Evaluation and Mitigation Program required to be implemented under Section 505-1 of the Federal Food, Drug and Cosmetic Act in connection with the regulatory approval of the Product by the FDA.
Found in
DYAX CORP contract
REMS Program. The Company's Risk Evaluation and Mitigation Strategies program for the Product Ravicti.
All Definitions
Found in
HYPERION THERAPEUTICS INC contract
