HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Newly Published Material From HDA and C4SCS

I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday!  Near the end of last month there was a spike in the number of things that need to be covered in RxTrace.  Two of them are important things from HDA and the Center For Supply Chain Studies.  I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS