Zdrowie i gospodarka · 09/12/2024

FDA Releases Guidance for Electronic Submission of Marketing Application Content for Bioresearch Monitoring Inspections

The Food and Drug Administration (FDA) has made available a new guidance document outlining the standardized format for electronic submission of marketing application content for bioresearch monitoring inspections, which will aid in the planning of inspections by the Center for Drug Evaluation and Research (CDER) and the conduct of inspections by the FDA's Office of Inspections and Investigations (OII).