Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Podcasts|March 4, 2011
Preparing for Future Trends in Risk Management
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Preparing for Future Trends in Risk Management
New legislation in the US, Europe and other countries have made product risk management a key priority for drug approval and continued marketing. To thrive in this new era, the pharmaceutical industry needs to incorporate new strategies and tactics.
Medical products companies will need to change their drug development and commercialization activities to anticipate and develop post-marketing surveillance and risk minimization activities that may be needed in the post-marketing period. Both of these activities are increasingly required by regulatory authorities throughout the world to ensure that the benefit to risk profile remains positive for patients using the medication.
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