FDA has three NDAs set for public advisory committee review at the end of March and early April, the first 'real' committee meetings in five months. Oops. Make that two.
On March 29, FDA will host its first new drug application focused advisory committee meeting in almost five months – assuming a sponsor is willing to go through with it.
It has been a long time since FDA last held a public advisory committee review of a pending new drug...
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
