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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The US Food and Drug Administration (FDA) recently warned a clinical trial sponsor for failing to submit an investigational new drug...
Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on lase...
Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requi...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
The 22-page guidelines feature examples of test systems that do and do not meet the definition of LDT. HSA does not classify researc...
02 Dec 2022
05 Dec 2022
06 Dec 2022