Application Integrity Policy (AIP)
Application Integrity Policy (AIP) is FDA's policy for the integrity of data or information submitted in an application. If it is suspected that an applicant has submitted false or misleading information, the data are thoroughly investigated. Submitting false or misleading information may result in FDA refusal to review submissions until certain requirements are met.
Featured Products
ISO 13485 Internal Auditor Checklist
Price: $95.00
Price: $95.00
Best Practices for Maintaining an IND and IDE Application with FDA
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
The IDE (Investigational Device Exemption) - It's Purpose and Preparation
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
Planning for a Successful Pre-IDE Meeting with FDA
Pre-IDE Meeting – Process- Submission preparation - presentation
Pre-IDE Meeting – Process- Submission preparation - presentation
