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FDA OGD releases updated ANDA checklist for eCTD

FDA releases GDUFA Performance Goals and Procedures mandating eCTD for ANDAs and DMF-II

FDA releases PDF Specification version 3.0

FDA releases PDFUA V Goals and Procedures for FY 2013-2017 mandate eCTD format for NDAs, BLAs and commercial INDs.

BIO endorses PDUFA V goals and procedures

Though outside the scope of PDUFA V, the Generic Pharmaceutical Association announces target agreement in September 2011 for user fees to assure adequate OGD resources to review ANDAs. Is eCTD format for ANDAs the next mandate?

IRISS-Forum Introduction

Implementation of Regulatory Information Submission Standards (IRISS) (pronounced ‘Iris’ – the flower) is conceptualized to be a global, open, multidisciplinary, non-profit organization dedicated to the implementation and widespread, successful adoption of electronic regulatory submission standards around the world.

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GlobalSubmit REVIEW and VALIDATE software for the FDA and for Life Sciences organizations around the world. Click here...

At Old Globe last night, in front row, fell asleep during first act and snored. More a reflection on my fatigue? http://t.co/ral3sXXu

by Antoinette Azevedo

Dalai Lama to visit San Diego in April (via @sdut) http://t.co/QSPD5UDe

by Antoinette Azevedo

Thanks to the Republican presidential campaign process for making 2011-12 so entertaining. Catch article on Perry in recent Vanity Fair!

by Antoinette Azevedo

@chelseahandler Loved snarky interview of Piers Morgan on occasion of first anniversary of his show on CNN.

by Antoinette Azevedo

@piersmorgan loved interview by chelsea handler on 1st anniversary of piers morgan show on cnn

by Antoinette Azevedo

Wed Mar 28
RAPS Preparing Compliant eCTD Submissions

Wed Mar 28
Regulatory Affairs Professional Society

Wed May 02
Regulatory Affairs Professional Society

Sat May 12 @11:30AM - 02:00PM
American Medical Writers Association

Sun Jun 24
Drug Information Association, 2012 Annual Meeting

Mon Oct 01
Preparing Compliant eCTD Submissions

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