What happens when the FDA acts like a biotech penny stock?
On Sunday, the FDA granted provisional clearance for convalescent plasma as a treatment for Covid-19, explaining the decision by citing a subgroup analysis from a study without placebo control. Those kinds of claims, when they come from biotech companies, tend to precede FDA rejections. What does it mean when they come from the FDA itself?
As STAT’s Matthew Herper and Adam Feuerstein write, the statements from FDA Commissioner Stephen Hahn mark a departure from the agency’s historically nuanced approach to communicating data. And, looking forward, sowing doubts about the FDA’s impartiality could be even more problematic when the agency begins weighing in on Covid-19 vaccines.
Read more.
On the same topic, yesterday we asked readers whether the FDA was wise to issue an emergency authorization for convalescent plasma. More than 65% said the data are too premature to justify the decision, while just 34% said it was the right move.
As STAT’s Matthew Herper and Adam Feuerstein write, the statements from FDA Commissioner Stephen Hahn mark a departure from the agency’s historically nuanced approach to communicating data. And, looking forward, sowing doubts about the FDA’s impartiality could be even more problematic when the agency begins weighing in on Covid-19 vaccines.
Read more.
On the same topic, yesterday we asked readers whether the FDA was wise to issue an emergency authorization for convalescent plasma. More than 65% said the data are too premature to justify the decision, while just 34% said it was the right move.
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