Guidance documents are not binding for FDA or the public. Guidance should be viewed as recommendations unless specific regulatory or statutory requirements are ...
Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a ...
Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not ...
About FDA Guidance Documents. Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and ...