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Titles
- Real-time oncology review (RTOR): guidance for industry1
- Referencing approved drug products in ANDA submissions2
- Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency1
- Risk evaluation and mitigation strategies: modifications and revisions2
- Rx Price Watch report: retail prices for widely used brand name drugs increase considerably prior to generic competition1