Comment from Hyman, Phelps & McNamara, P.C.

Summary: Hyman, Phelps & McNamara, P.C. is submitting comments on behalf of a client regarding the FDA's draft guidance on responding to Form 483 observations. The firm argues that the guidance's "one size fits all" format and content expectations are impractical for complex investigations, and that requirements for signing all attachments and disclosing consultant information are administratively burdensome and could chill the availability of expert support.