There are 3 Updates appearing in the Federal Register for 21 CFR Part 314. required under § (d (d)(4) (if an anti-infective drug), (d)(5), (d and (vi) Any patent certification or statement required under section of the.
Guideline content contained in Section H.H., "Integrated Summary of Safety Information [ 21 CFR (d) (5) (vi)]" and Section "The Format and Content.
E. Uncontrolled Clinical Studies [ 21 CFR (d)(5)(iii)]. 22. 1. Overview. 22. 2. .. (d)(5) (vi )(~) of this section concerning a summary of information about the. A reference to information submitted to the agency by a person other than the applicant is required to contain a written statement that authorizes the reference and that is signed by the person who submitted the information. The application may provide additionally for the use of alternatives to meet any of these requirements, including alternative components, manufacturing and packaging procedures, in-process controls, and analytical procedures. If an applicant with a pending application voluntarily makes a patent certification for an untimely filed patent, the applicant may withdraw the patent certification for the untimely filed patent. The draft review, in turn, receives a peer review by the group leader and branch chief. The final rule requires electronic submission, unless waived in certain circumstances, 21 cfr 314.50 d 5 vi registration and listing information. These formats are modified and fine tuned during the review process. CFR Toolbox LII on your phone: View eCFR.