PDA Regulatory Commenting
The Regulatory Affairs and Quality Advisory Board (RAQAB):
- 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 Denyse Baker, PDA Senior Advisor for Scientific and Regulatory Affairs, baker@pda.org.