Evolution in Strategies for Getting FDA Approvals

Pharma must adjust rapidly to a new regulatory world dominated by FDA’s new drug safety authority. Post-marketing risk management plans are likely to be the key to surviving in the new climate. But beware: they change the relationship of pharma companies to doctors and patients. And they also drastically change the nature of pre-approval filings to FDA.

Cole Werble

There is a new regulatory acronym, REMS, that everyone in the pharma business needs to learn and understand. Risk Evaluation...

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