Newsletter | June 26, 2014

06.26.14 -- FDA's First Draft Guidance Under DSCSA: What It Tells Us And What It Doesn't

Pharmaceutical Online Newsletter
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» From The Editor
FDA's First Draft Guidance Under DSCSA: What It Tells Us And What It Doesn't
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
On June 10, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang of KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
Featured Focus: Manufacturing
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