Global regulatory updates
Follow FDA, EMA, PMDA, MHRA, and other agencies across approvals, warnings, inspections, guidance, and drug policy signals.
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🇺🇸Regulatoryfederalregister.gov
Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidanc...
Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance...
Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination...
Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov
Medicare and Medicaid Programs; Application From DNV Healthcare USA Inc. (DNV) for Continued CMS-Approval of its Hospital Accreditation Program
This notice acknowledges the approval of an application from DNV Healthcare USA Inc. (DNV) for conti...
Federal RegisterOriginal source
🇺🇸Regulatoryfederalregister.gov
Proposed Information Collection Activity; Diaper Distribution Demonstration and Research Pilot Beneficiary and Organizational Survey and Beneficiary Report
The Office of Community Services (OCS), Administration for Children and Families (ACF), Department o...
Federal RegisterOriginal source