The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the considerations on identifying and responding to deficiencies in premarket submissions. The document supersedes the one of the same title issued on November 2, 2000.
The revised document further clarifies the content and format of a deficiency letter and includes a new list of examples of deficiencies and applicant responses…
