PDA Regulatory Commenting

Keeping abreast of regulations and requirements is an ongoing concern for the pharmaceutical manufacturing community. When new and updated guidance is published, PDA Members work together to provide feedback regarding the content of the draft documents, which include proposed regulations, technical guidance documents, inspection procedures, policy statements, Pharmacopoeia proposals, standards setting activities, and other related items developed by the global regulatory bodies (e.g. US FDA, EMA, WHO, USP, ANVISA). The contributions of PDA’s members ensure a broad industry perspective is presented and considered for inclusion or revision of the draft document. Below are the comments submitted by PDA on behalf of its members to a variety of global regulatory and pharmacopeial bodies. The documents are available for review to all PDA Members as a valuable reference for staying up to date on compliance-related topics and concerns.

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For more information or to suggest a topic for PDA commenting, please contact Carrie Horton, Regulatory Affairs Program Manager.

2025 PDA Regulatory Comments

2024 PDA Regulatory Comments

2023 PDA Regulatory Comments

2022 PDA Regulatory Comments

2021 PDA Regulatory Comments

2020 PDA Regulatory Comments

2019 PDA Regulatory Comments

2018 PDA Regulatory Comments

2017 PDA Regulatory Comments

2016 PDA Regulatory Comments

2015 PDA Regulatory Comments

2014 PDA Regulatory Comments

2013 PDA Regulatory Comments

2012 PDA Regulatory Comments

2011 PDA Regulatory Comments

2010 PDA Regulatory Comments

2009 PDA Regulatory Comments

2008 PDA Regulatory Comments

2007 PDA Regulatory Comments

2006 PDA Regulatory Comments

2005 PDA Regulatory Comments