The US Food and Drug Administration (FDA) has announced plans for a future pilot program intended to facilitate the real-time ...
The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and ...
The US Food and Drug Administration (FDA) and representatives from industry have reached an agreement in principle on ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing ...
Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of ...
Fewer than half of the studies funded by the US National Institutes of Health (NIH) examined sex differences, despite a 2016 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...
Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline, but a speaker ...
CDSCO proposed the system in January 2026 as part of an amendment to the New Drugs and Clinical Trial Rules, 2019. The system ...
Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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