Nearly three months after Canadian generics firm Apotex was put on import alert by the US Food and Drug Administration (FDA), the agency has released the text of a Warning Letter issued to the company ...
The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
Kathleen Hurley is the founder of Sage Inc., a tech company that offers SMB businesses infrastructure solutions and next-gen technology. As data becomes everything to everybody, it’s crucial to ...
Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
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