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Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,
Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,
linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. 7 An integrative (vs. Accessed 3 December 2022.
In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing processimprovements, and ensure that both regulator and industry resources are devoted to the most critical issues.
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