Zdrowie i gospodarka · 23/09/1997

FDA Releases Guidance on Archiving NDA Submissions in Electronic Format

The Food and Drug Administration (FDA) has made available a guidance document outlining the process for submitting new drug application (NDA) records and documents in electronic format to the Center for Drug Evaluation and Research (CDER) for archival purposes, aiming to reduce paperwork for applicants and streamline the submission process.