During the opening session of the recent DIA Electronic Submissions Conference in San Diego, Gary Gensinger, Deputy Director, Office of Business Informatics at CDER spoke about the not-too-distant future at the FDA when electronic submissions will become mandatory. Under the draft PDFUA V bill, electronic submissions will be mandated and Gary provided us a timeline for the implementation under the proposed mandate.
In December 2012, the FDA will release draft guidance for this new era, which, among other things, will require electronic submission. The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.
To find more information please click here: THEeCTDSUMMIT: Electronic Submissions Mandated in 2015
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