FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
With the public health emergency and the national emergency declaration expected to expire on May 11, the FDA will be letting some guidance documents expire along with it.
In a document published Friday in the Federal Register, the FDA said that of the 72 Covid-19 guidances that are still active, 22 will no longer be in effect when the declarations expire.
Those guidance docs that are being cut, and which typically offered some leniency from the FDA due to the constraints of the pandemic, include ones related to manufacturing considerations for cell and gene therapies, nonhuman primate supply constraints, statistical considerations for clinical trials and more.
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