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COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016.  Two of the guidances, the draft from FDA published in April 20...

If you are manufacturing an authorised veterinary medicine you must comply with the Good Manufacturing Practice (GMP) standards and obtain a Manufacturing Authorisation (ManA) unless the medicine is for small non-food producing pet animals. If your...

Top News St. Joseph Health (CA) will pay $2.14 million to settle OCR charges that it exposed the information of 32,000 patients for a full year in 2012-2013 when it brought a server online using default security settings that allowed its contents to...

By: Howard Sklamberg, J.D., Lou Valdez, and Donald Prater Reflecting the broad scope of our transatlantic dialogue, we engaged on an array of issues, including supply chain safety, quality metrics, risk-based surveillance, data integrity, mutual reliance...

By: Howard Sklamberg, J.D., Lou Valdez, and Donald Prater Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy On a recent trip to Brussels, our FDA delegation met with many of our European Union (EU) regulatory...