eCTD Submissions Q&A

Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD. We...

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Federal Information Processing Standards (FIPS) and MD5 Checksums

There is an old security requirement that the United States Federal government imposes that will affect the FDA. That security requirement, otherwise known as Federal Information Processing Standards (FIPS), does not allow any program to calculate MD5 checksums, as defined in the eCTD 3.2 specification. This is a potentially huge problem for everyone creating eCTD submissions. What is the FIPS? The Federal Information Processing...

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