USA FDA - Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Catapult's regulatory round-up - July)
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21 février 2024
- doi: 10.58079/vvni
info:eu-repo/semantics/openAccess
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adelage, « USA FDA - Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Catapult's regulatory round-up - July) », ELSIBI, ID : 10.58079/vvni
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The FDA as published a new guidance describing factors considered by the FDA when determining whether an applicant has demonstrated good cause for its noncompliance with the timetable for completion of postmarketing requirements (PMRs) milestones as required under section 505(o)(3). This guidance also provides information on relevant procedures including how to communicate with FDA regarding PMR compliance, submission of an explanation of the circumstances that led to noncompliance, and how ...