Zdrowie i gospodarka · 25/07/2014

FDA Announces Revised Draft Guidance for Electronic Regulatory Submissions in Human Pharmaceutical Product Applications

The Food and Drug Administration (FDA) has released a revised draft guidance outlining Electronic Common Technical Document (eCTD) specification requirements for certain human pharmaceutical product applications, including new drug applications, abbreviated new drug applications, and investigational new drug applications, in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA). The draft guidance is open for public comment and is expected to be finalized within 24 months.