Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says
As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.
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Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
Providing information in a pre-IND meeting request will facilitate a more efficient development process, agency says in a new guidance; generally, there is insufficient information to assess if and when an emergency use authorization might be appropriate when a sponsor first enters discussions with the FDA.
FDA’s Peter Marks and Janet Woodcock will be on the bridge for Operation Warp Speed; Moncef Slaoui says early clinical data on one vaccine candidate makes him confident that a few hundred million doses of a vaccine can be available by the end of the year.