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FDA
FDA Extends Comment Period on SIUU Draft Guidance
The United States Food and Drug Administration (FDA) has extended the comment period for comments on the revised draft guidance…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FDA Releases Draft Guidance on Unapproved Use Communications from Firms to…
Recently, the United States Food and Drug Administration (FDA) released a draft guidance document, Communications from Firms to…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…
FDA Issues Draft Guidance on Postmarketing Requirement Non-Compliance
Recently, the United states Food and Drug Administration released a draft guidance for sponsors about the way the agency will…
FDA Issues Proposed Patient Medication Information Rule
Earlier this summer, the United States Food and Drug Administration (FDA) released a long-awaited proposed rule regarding the…
FDA Issues Draft Guidance on Decentralized Clinical Trials
Recently, the United States Food and Drug Administration (FDA) issued a Draft Guidance, “Decentralized Clinical Trials for Drugs,…
OPDP Untitled Letters Are Back
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent its first untitled…
FDA Seeking Comments on Quantitative Claims in DTC Prescription Drug…
On April 25, 2023, the United States Food and Drug Administration (FDA) published a request for comments on a planned survey on…