Qiu of Liu, Shen & Associates analyses two recent CNIPA decisions that provide insights into the application of the good ...

Medical affairs teams produce evidence-based, non-promotional scientific content for healthcare professionals (HCPs), while ...

CSA is “a risk-based approach for establishing and maintaining confidence that software is fit for its intended use,” ...

The U.S. Food and Drug Administration has introduced ... The recommendations in this guidance can help manufacturers and processors comply with requirements for current good manufacturing practices ...

PMO governance is a strategic tool for organizations working with the FDA, ensuring projects align with regulatory frameworks ...

An investigation by The Imprint reveals overmedication and spotty enforcement of federal requirements that child welfare ...

The budget resolution vote in the House of Representatives has been postponed after GOP leaders were unable to win over ...

The course also reviews general good documentation practices, incorporating the requirements of the FDA's Guide to Industry Data Integrity and Compliance with CGMP.

Instead, the GRADE Working Group has recommended developing ungraded best or good practice statement (GPS ... to access the best available evidence-based guidance to make their decisions.