FMD-145 - Release of the Establishment Inspection Report (EIR)
Detailed guidance document from FDA and regulatory agencies.
Document Details
Field Management Directive
July 31, 2019
July 31, 2019
e53a05d1-8ed0-50fa-ae90-1ebc6d94a1a7
Related Documents
E3 Structure and Content of Clinical Study Reports
Field Management DirectiveJuly 1, 1996Center for Drug Evaluation and Research
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
Field Management DirectiveSeptember 1, 1997Center for Drug Evaluation and Research
Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the US Food and Drug Administration: Guidance for Industry
Field Management DirectiveNovember 1, 2017Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.