compliance news
Conduct of Clinical Trials During the COVID-19 Public Health Emergency
FDA issues guidance for Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
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.
