이 기사의 번역을 준비하고 있습니다. 그동안 영어 원문을 임시로 표시합니다.
비즈니스 · 2018. 4. 9.1 분 읽기
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials." This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →