Zdrowie i gospodarka · 28/01/1999

FDA Releases Guidance for Electronic Regulatory Submissions

The Food and Drug Administration (FDA) has made available a guidance document outlining general considerations for submitting regulatory information in electronic format to the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). This move aims to streamline the process and improve efficiency in handling and reviewing electronic submissions.