Welcome to e-SubmissionsSolutions.com

FDA releases version 3.1 of PDF Specifications

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.

PhRMA endorses PDUFA V

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?

Generic Pharmaceutical Association endorses FDA GDUFA recommendations

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.

Please inquire about special considerations for members of BIOCOM.org. Contact us for more information.

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

Sage templates to be enhanced with content requirements detailed in FDA OGD completeness checklist for DMF-II for API submissions

by Antoinette Azevedo

Thanks to Kathie Clark re FDA OGD DMF draft guidance called for in GDUFA. Describes completeness checklist & user fee process & ANDA review

by Antoinette Azevedo

FDA reviews provisions of FDASIA 2012 that impact data standards, their own IT infrastructure, change management for them & industry

by Antoinette Azevedo

Lorenz announces US availability of dB One - low cost, self-installing, easy-to-use eCTD publishing tool targeted at low-volume scenarios

by Antoinette Azevedo

Looking forward to seeing further news about FDASIA & the "UFAs" @ this week's DIA EDM-ERS/eCTD conference in baltimore

by Antoinette Azevedo

No events

Welcome to e-SubmissionsSolutions.com

IRISS-Forum Introduction

BIOCOM.com Members

GlobalSubmit

Follow Us

Latest Tweets

Who's Online

Upcoming Events

Food & Drug Administration

Popular Pages