Health IT Analytics December 17, 2018
New guidance from the FDA details how drug manufacturers can maintain health data integrity to ensure the safety of their products.
The FDA has released new guidance aimed at helping drug manufacturers ensure data integrity and product safety.
The document is an update to the FDA’s 2016 draft guidance on the topic and will ensure industry compliance with current good manufacturing practice (CGMP).
The new recommendations will help drug manufacturers identify lapses in data integrity, implement best practices, and ensure consistent commitment to data quality and accuracy.
“Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
“Overseeing the quality and safety of pharmaceutical manufacturing...
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