Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 09/04/20181 min di lettura
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials." This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →