compliance news
FDA Issues Draft Guidance for Remote Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
Draft FDA Guidance for Computer Software Assurance for Production and Quality System Software
The FDA issued a draft Guidance for Computer Software Assurance for Production and Quality System Software.
Conduct of Clinical Trials During the COVID-19 Public Health Emergency
FDA Issues Guidance on Remote Inspections
FDA Remote Inspections
FDA Guidance on Providing Regulatory Submissions in Electronic and Non-Electronic Format
FDA issues guidance for Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations