Regulatory Resources

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 Project Manager, Regulatory Affairs, [email protected].

Comments Archive

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