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 ...
Fewer than half of the studies funded by the US National Institutes of Health (NIH) examined sex differences, despite a 2016 ...
Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The trend for the timing of initial marketing authorization applications (MAAs) to be less predictable is slowly reversing ...
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program ...
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