PDA Regulatory Commenting

Each PDA Technical Advisory Board:

  • identifies current regulatory and quality issues affecting  the development, manufacturing and quality of healthcare products,
  • advises PDA on the impact of such issues,  
  • recommends a plan of action for PDA response, and
  • develops and makes recommendations to the PDA Board of Directors on association positions.

These issues may 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).

For more information or to suggest a topic for PDA commenting, please contact Carrie Horton, PDA Director of Regulatory Affairs, horton@pda.org.

Comments Archive

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