‘Alternative Pathway’ Products Are Key New Challenge For FDA, Woodcock Says
US FDA will have to wrestle with a proliferation of medical products that are coming to market via ‘alternative pathways’ that do not neatly fit under – or sometimes deliberately seek to avoid – the agency’s regulatory authorities, acting commissioner says.
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FDA is formally asking Congress to weigh in on the best approach to regulate CBD in consumer products. That provides another target for legislative attention that may mean that FDA’s core drug regulatory activities stay comfortably out of the spotlight.
Commissioner nominee strikes an optimistic note as former FDA heads raise concerns about the decrease in agency credibility during the pandemic.
CDER Hiring Is Booming: Flexibility Of Remote Work During Pandemic Helps Drive Numbers, Cavazzoni Says
Employment totals have also been aided by a (surprisingly) low attrition rate during the pandemic and CDER’s full use the ‘Cures’ authorities; 20% of CDER’s workforce has been hired under Cures.