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A look at the blended approach and other options for an
outsourced pharmacovigilance model and their benefits for small pharmaceutical
companies. This article provides advice on the steps required to complete a
successful PV outsourcing project.
US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you.
Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. View More