美国FDA 指导原则 第117和507部分中“独家经营”豁免的行业适用指南草案 英文原版.pdfVIP

Contains Nonbinding Recommendations Draft-Not for Implementation Application of the “Solely Engaged” Exemptions in Parts 117 and 507: Guidance for Industry Draft Guidance This guidance is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or