A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
Guidance for Industry - A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers
Source: fda.gov
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Notifying FDA of a Discontinuance or Interruption in Manufacturing
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act
Source: fda.gov
Tobacco Health Document Submission (Revised)
Learn more about who submits tobacco health documents to FDA, compliance policies, information to include, and how and when to submit health documents.
Source: fda.gov
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
FDA provides guidance for tobacco manufacturer registration and product listing.
Source: fda.gov
FDA Updates Electronic Systems in Clinical Investigations Guidance
The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017 on the requirements of 21 CFR Part 11 and use of technologies in clinical investigations.
Source: natlawreview.com