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FDA
FDA Releases Finalized Guidance on Use of Real-World Data in New Drug and…
Recently, the United States Food and Drug Administration (FDA) finalized two guidance documents that outline how sponsors can use…
New Report Outlines a Roadmap for Restoring Public Trust in the FDA
The Hastings Center recently released a report with a roadmap on how the United States Food and Drug Administration (FDA) can…
FDA Announces Small Entity Compliance Guide on DTC Radio and Television…
On December 27, 2023, the United States Food and Drug Administration (FDA) announced a new small entity compliance guide (SECG),…
Comments Praise and Call for Clarification on FDA DAP Draft Guidance
The United States Food and Drug Administration (FDA) received more than 130 comments on its draft guidance on clinical diversity,…
FDA Releases Final Rule for Direct-to-Consumer Prescription Drug…
Recently, the United States Food and Drug Administration (FDA) released the final rule for Direct-to-Consumer Prescription Drug…
FDA Extends Comment Period on SIUU Draft Guidance
The United States Food and Drug Administration (FDA) has extended the comment period for comments on the revised draft guidance…
FDA Finalizes Guidance on Real World Evidence in Supporting Drug Approvals
The United States Food and Drug Administration (FDA) recently finalized guidance on real-world evidence (RWE) and real-world data…
OPDP Issues Untitled Letter to Exeltis
On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an…
FDA Releases Draft Guidance on Unapproved Use Communications from Firms to…
Recently, the United States Food and Drug Administration (FDA) released a draft guidance document, Communications from Firms to…
Policy and Medicine Compliance Update October 2023 Issue Features: Complex…
We begin our coverage in Policy and Medicine Compliance Update this month by examining the complex world of medical education. The…