Opinion & analysis

US FDA Looks To Standardize Premarketing Safety Assessments

A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.

US FDA Looks To Standardize Premarketing Safety Assessments

‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

FDA’s Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?

Commission Looks Set To Expand MDR Extension So Notified Bodies Can Focus On High-Risk Devices

Commission Would Back Limited Expansion Of Products Covered By MDR Grace Period

Contamination In Common OTC Antacid Adds To FDA’s API Impurity Concerns

US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

Amarin CEO: Consumers Have Heard About Omega-3 Heart Benefits ‘Too Long’

Sanofi Offloads Two German OTC Brands, New CEO Prepares To Make Mark

Ranitidine Recalls Begin In Europe As Regulators Take Action

Novartis Swaps Two AveXis Executives For One Following Zolgensma Data Manipulation