How a Rapid and Well-Messaged US FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts
Consultant examines why FDA seems to be accomplishing so much under FDA Commissioner Gottlieb’s leadership and how this could inform future leadership selections.
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US FDA Wants More Examples Of Real-World Data Use
CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.
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Did FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar have a change of heart on importation? Or are they being pressured from above?
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Although a sponsor may conclude that a long-term follow-up protocol is not necessary for a gene therapy, FDA may have a different interpretation, and the agency won't let studies start if that's the case, draft gudiance states.