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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

ORA, CDER Align on Manufacturing

Nov 3, 2017, 09:39 AM
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Nov 3, 2017, 08:40 AM

The U.S. FDA continues to restructure its field activities, moving away from a geographic focus to a structure based on program-aligned commodity areas. As part of this process, CDER and the Office of Regulatory Affairs (ORA) recently began implementing a concept of operations agreement that better aligns drug review programs with facility inspections. Both field and review staff will work together as part of a team-based approach that provides a holistic overview of all elements that create risk, from drug substance to drug product to manufacturing.

The Agency hopes this alignment will help prevent manufacturing delays due to inspection issues.

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