Miscellaneous Data Submissions Sample Clauses

Miscellaneous Data Submissions. If applicable, the Awardee must submit to the Government all Point Papers, Briefings, Technical Performance Plans , Program Development Plans (PDP), target product profile (TPP), Regulatory Strategy, Technology Transfer Report and Gap Analysis, Formulation Development, Feasibility and Optimization Reports, United States Army Medical Research and Material Command Animal Care and Use Review Office (USAMRMC ACURO) Approvals, Human Resources Operations Branch (HROB) Approvals, Technical Presentations and Publications, and any formal technical reports that have been prepared for eventual submission to FDA or other regulatory agencies. Examples include the following reports related to: pharmaceutical development, manufacturing development, manufacturing validation, completed batch records, certificates of analysis, analytical development and validation, drug substance and product stability, nonclinical testing, and clinical testing. Examples include clinical performance and clinical quality documentation.