Tag: accelerated approval disclosure

accelerated approval disclosure

Regulatory/FDA

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

March 28, 2022 – As FDA Commissioner Robert Califf, M.D., determines how to fulfill his promise to re-examine the agency’s accelerated approval pathway and Congress continues to push for action, the FDA’s Office of Prescription Drug Promotion (OPDP) is tackling one piece of the puzzle: How well consumers understand the limitations of accelerated approval drugs […]

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Regulatory/FDA

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Oct. 22, 2018 – Broadcast disease awareness ads, accelerated approval disclosures in direct-to-consumer (DTC) ads, and physician interpretation of drug information in scientific publications as compared to promotional pieces are the subjects of future Office of Prescription Drug Promotion (OPDP) research, according to notices published Oct. 17 in the Federal Register. “All three of these […]

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