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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Any program changes would not occur until after a thorough assessment, the agency said.
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.