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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.