Regulatory Comments/Resources

Regulatory authorities around the world update or issue new regulations and guidances.  Generally a draft document is issued and a comment period is assigned from publication.  Such periods may vary in length from 45 days after publication (e.g. WHO) up to 180 days (e.g. some FDA or EMA documents). RAQAB reviews these draft documents and decides whether or not PDA should submit comments.  If yes, as Task Force is formed and a response is generated.  Those comments are vetted throuogh both RAQAB and the PDA Board of Directors prior to submission.  A link to these responses, which are posted on the PDA website, may be found below, as well as links to global regulatory agency websites.

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 
Global Health Authorities and Organizations