21 C.F.R. §10.115 - Good guidance practices

Cite as21 C.F.R. §10.115
    • This document is available in original version only for vLex customers

      View this document and try vLex for 7 days
    • TRY VLEX
2 books & journal articles
  • White House Orders, Bulletins, and Memoranda on Regulation
    • United States
    • ABA General Library Federal Administrative Procedure Sourcebook, Fifth Edition 2016
    • January 1, 2016
    ...57 See FDA, “Administrative Practices and Procedures; Good Guidance Practices,” 65 FR 7321, 7322-23 (proposed Feb. 14, 2000). 58 21 C.F.R. § 10.115; 65 FR 56,468 (Sept. 19, 59 Pub. L. No. 106-554, § 515(a) (2000). The Information Quality Act was developed as a supplement to the Paperwork Re......
  • Naked Price and Pharmaceutical Trade Secret Overreach.
    • United States
    • Yale Journal of Law & Technology Vol. 22 No. 1, January 2020
    • January 1, 2020
    ...("Guidance documents describe FDA's interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated (41) See Robin Feld......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT