Agency responses focus on substantive comments
But the agency’s response will mostly be to the handful that are substantive.
on public comment campaigns
S
Steven BallaGeorge Washington University · co-director of the Regulatory Studies Center
On the same topic: Biotech & medicine
More →“Novartis now expects to speak with the FDA about a potential accelerated approval of pelabresib before the end of the year, CEO Vas Narasimhan told investors on a call Tuesday.”
“The industry has gotten more consolidated. Prices are higher than ever. Access is worse than ever.”
“The rising costs are unsustainable for individuals, for businesses, and for the country. What kind of intervention is a different question.”