A FREE SEARCH & DISCUSSION PLATFORM FOR COMPLIANCE INFORMATION
Developed by OneSource Regulatory (OSR), MyIndago™ is the first FREE search and discussion platform that allows pharmaceutical and biotech professionals to search U.S. Food & Drug Administration enforcement communications (Warning Letters, Notice of Violation/Untitled Letters) in the areas of advertising, promotion, and healthcare compliance. Additional correspondence is added to the MyIndago™ platform on an ongoing basis, so stay tuned for all the latest.
YOUR ONE-STOP TO SEARCH, COMMENT, & COLLABORATE
MyIndago™ is the one resource you need to search, annotate, archive, comment, and collaborate around health authority enforcement communications.
MyIndago™ includes information from the following divisions:
- FDA Office of Prescription Drug Promotion (OPDP)
- FDA Advertising and Promotional Labeling Branch (APLB)
- FDA Center for Device and Radiological Health (CDRH)
- FDA Advertising & Promotion Regulations/Guidance Documents
- Center for Veterinary Medicine (CVM)
Some of the materials you can access include:
- Guidance for dietary and nutritional supplements
- Guidance focusing on animal health
- U.S. Corporate Integrity Agreements (CIAs)
- Advisory opinions from the Office of Inspector General (OIG)
- FDA warning letters addressing topical skin care preparations, such as drug claims made for products marketed as cosmetics
MyIndago™ will be updated when new enforcement actions are communicated from these health authorities. New regulatory and compliance communications are added daily, including communications from health authorities around the world.
Upcoming additions to look for:
- FDA Inspections (EIRs, 483, Warning Letters)
- U.K. Code of Practice Cases (PMCPA)
- U.K. Regulations
- E.U. Regulations