de novo

End of financial year

Out They Go – FDA Clears the Store of Guidances

By Arthur Brandwood | 25 October, 2019
In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of...
Uncertainty

Risk vs. Benefit FDA guidance gets to grips with uncertainty

By Arthur Brandwood | 27 September, 2018
Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...

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