USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy,...
Chemistry, manufacturing and controls (CMC) are an integral step in creating an effective biological product — and a crucial element of an effective biologics...
USA – Industry urges FDA to do more to help companies prepare for DSCSA
The pharmaceutical industry urged the US Food and Drug Administration (FDA) to take a more “assertive and forward-leaning” approach in assisting pharmaceutical manufacturers prepare...
USA – FDA warns industry about potential data integrity issues with third-party labs
The US Food and Drug Administration (FDA) is warning medtech sponsors and manufacturers to double-check the work of third-party testing laboratories before their data...
USA – FDA finalizes guidance on charging for investigational drugs
The US Food and Drug Administration (FDA) on 14 February finalized guidance specifying the circumstances when sponsors can charge for an investigational drug in...
USA – FDA issues new draft guidance on data monitoring committees
The US Food and Drug Administration (FDA) on Monday issued a new draft guidance advising certain product sponsors to establish data monitoring committees (DMCs)...
USA – FDA modernizing pharmacovigilance oversight with AI tools
To modernize its pharmacovigilance efforts, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) is using artificial intelligence (AI) to...
USA – FDA finalizes best practices guide for postmarketing safety studies
The US Food and Drug Administration (FDA) has finalized a guidance describing best practices for its staff in conducting postmarketing safety surveillance of marketed...
USA – Clinical trials: FDA proposes new standards for collecting race, ethnicity data
The US Food and Drug Administration (FDA) is outlining a standardized approach for collecting and reporting on race and ethnicity data in clinical trials...
USA – FDA issues QMSR final rule with 2-year transition period
The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a...
USA – FDA: Genome editing therapies may use accelerated approval pathway
The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors developing gene therapy products that incorporate genome editing (GE) of human...
