Tag Archives: Drug Evaluation and Research

Adverse Event Reports Go Digital Only

Image via Wikipedia FDA, this morning, walked media through its proposed regulations requiring that pharma companies submit post-market adverse event reports through an electronic format. This is being done to help eliminate time and cost wasted on paper submissions. “This change will enhance FDA’s ability to rapidly identify new safety concerns and share safety information […]
Posted in Regulatory, Safety | Also tagged , , , , | 1 Comment
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