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.
Comments Archive
2025 PDA Regulatory Comments
- PDA Comments FDA 2024-N-0002 Best Practices for FDA Communication Draft Report 3 February 2025 (212 KB)