Bubble Gum Badge: An FDA His- Story is a glimpse of what the USFDA does well and what it needs to improve on according to audit reports from the Health and Human Services (HHS) Office of Inspector General (OIG). Here, Stone shares about the documented regulatory affairs 21 CFR compliance experience and advocate for human subject protection and his twelve years of U. S. Food and Drug Administration experience. The book discusses specialized clinical trial regulatory review strategy for oncology therapies (vulnerable patient populations included), cardiovascular disease, HIV, vaccine studies, pain management, and other related health care product subjects. Thus, the book looks into:
- Human Subject Protection / ICF process & document review
- Protocol data-validation Auditing / Quality Management / SOP audits
- Bioequivalence Clinical & Laboratory, GMP, cGMP, GLP non-clinical & clinical, GCP, and ICH
- Computer system validation & 21 CFR part 11 compliance / LIMS / Data Management System compliance
- FDA IRB & audit Training and continuing education presentations on FDA Regulatory Strategy
Informative, insightful, and filled with wisdom, Bubble Gum Badge: An FDA His- Story is an interesting and revealing read beneficial to everyone – providing knowledge and a better understanding about the issues facing FDA and the public health.