‘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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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.
The public hearing on cannabis and cannabis-derivative products also included calls for Good Manufacturing Practices to be imposed.