共 50 条
- [21] An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application Therapeutic Innovation & Regulatory Science, 2019, 53 : 254 - 263
- [26] An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019, 53 (02) : 254 - 263