Regulatory Guidance
Articles
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Sound Advice
This year, pharma regulators faced their own music
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Regulatory Rewind
A mix of the biggest hits from 2018
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An Injection a Day
Premature promises about cell therapies create expectations ripe for disappointment
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Bio's Bad Apples
Can unproven therapies spoil the sector’s sweet success?
News
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FDA announces new regulatory pathway for generics
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FDA issues new gene therapy guidances
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FDA pushes social media sites to do more to curb opioid sales
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FDA releases new guidance to speed generic drug review