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May 06, 2016

Do you know where your suppliers are when it comes to eDMFs?

Pharmaceutical packaging suppliers have just one year before all U.S. Drug Master Files (DMFs) will need to be submitted electronically. As we explained earlier this year, DMF submissions and related documents will need to be filed electronically with FDA in the eCTD format by May 5, 2017, or they will be rejected. FDA states that there are no exceptions.

There is some concern that not all Type III DMF holders of packaging component and raw materials will be ready to meet FDA’s new eDMF requirements. Peter Schmitt, managing director and cofounder of Montesino Associates, told PMP News that “it is not clear that holders of Type III DMFs realize that ‘the clock is ticking.’ ” Frank Bieganousky, also managing director and cofounder of Montesino Associates, warns that delays could impact pharmaceutical companies that rely on DMF Letters of Authorization in their own FDA submissions. And Dwain L. Sparks of YourEncore expects the DMF changes to be “confusing to all parties.”

Packaging Digest | Read Article »

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