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.
“Because these COVID-19 guidances will not be needed when the PHE declaration expires, FDA is not extending them. In other instances, the science behind certain recommendations has advanced, and FDA may want to update certain guidances to reflect new data,” the FDA said.
However, some guidance documents will not be going away immediately — 22 others can be discontinued, but with a “wind-down” period. Those guidances will remain in effect for an extra 180 days after the expiration, lasting until Nov. 7. These include a guidance about convalescent plasma, vaccine development, manufacturing inspections, and certain REMS requirements.
A total of 24 related guidances will still be retained but will have some changes made after the expiration of the declaration, which includes ones related to EUAs for vaccines to prevent Covid-19, the development and licensure of Covid-19 vaccines, and particulars around developing medicines to treat the virus.