What scientific papers and research studies were referenced to justify the FDA's (Food and Drug Administration) approval of DIVOL?

FDA Approval of DIVOL: Scientific Papers and Research Evidence

The FDA approval of DIVOL was not referenced in any of the provided evidence, as none of the materials contain information about a drug called DIVOL or its approval process.

FDA Drug Approval Process Overview

The FDA drug approval process is rigorous and typically follows a standardized pathway:

1. Pre-clinical testing: Laboratory and animal studies to assess safety and biological activity
2. Investigational New Drug (IND) application: Allows clinical trials to begin
3. Clinical trials: Phase 1-3 studies evaluating safety, efficacy, and optimal dosing
4. New Drug Application (NDA): Formal request for FDA approval including all data
5. FDA review: Comprehensive evaluation of all submitted evidence
6. Post-marketing surveillance: Continued monitoring after approval

General FDA Approval Requirements

Based on general knowledge of FDA processes:

• Drug approvals typically require substantial evidence from adequate and well-controlled investigations 1
• The average time from pre-clinical testing to approval for new drugs is approximately 12 years 1
• Development costs for new drugs can exceed $1 billion 1

Types of Evidence Used in FDA Approvals

While not specific to DIVOL, FDA approvals generally rely on:

• Randomized controlled trials: Primary evidence for safety and efficacy
• Pharmacokinetic/pharmacodynamic studies: Sometimes sufficient for modified-release formulations without additional clinical efficacy studies 2
• Real-world evidence (RWE): Increasingly being incorporated into FDA approval decisions 3

Examples of Evidence in Other Drug Approvals

For context, here are examples of evidence used in other FDA drug approvals:

• Atezolizumab: Approved based on a single-arm, multicentre, phase 2 trial showing objective response rates of 15% overall and 26% in patients with high PD-L1 expression 4
• Nivolumab: Received FDA approval in 2017 as second-line therapy for hepatocellular carcinoma based on a single-arm study demonstrating an objective response rate of 14.3% 5

Important Considerations

• The FDA approval process requires substantial evidence of both safety and efficacy
• For specific information about DIVOL's approval, one would need to consult:
  • The FDA's approval documents
  • The drug's label/package insert
  • Published clinical trials that supported the application

Conclusion

Without specific evidence about DIVOL in the provided materials, it's not possible to identify which scientific papers and research studies were referenced to justify its FDA approval. To obtain this information, one would need to review the FDA's approval documents for DIVOL, which are typically available through the FDA's website or through a Freedom of Information Act request.