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FDA Issues Draft Guidance for Remote Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities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The FDA issued a draft Guidance for Computer Software Assurance for Production and Quality System Software.
FDA Responses to Good Clinical Practice Inquiries
FDA answers GCP questions
Conduct of Clinical Trials During the COVID-19 Public Health Emergency
FDA Issues Guidance on Remote Inspections
FDA Remote Inspections
FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials
FDA Guidance on Conduct of Clinical Trials during COVID-19
FDA guidance on the conduct of clinical trials of medical products during the coronavirus (COVID-19) Public Health Emergency
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
Final FDA Guidance on Bioanalytical Method Validation
FDA Final Guidance on Bioanalytical Method Validation
FDA releases final rule on Acceptance of Data from Clinical Investigations for Medical Devices
FDA Guidance for IRB Waiver or Alteration of Informed Consent
The United States Food and Drug Administration (FDA) issued a guidance for immediate implementation to Sponsors, Investigators, and Institutional Review Boards for the waiver of alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects.
