FDA Statistics on NDAs, INDs and ANDAs

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry. Gary Gensinger provided his usual update on eSubmissions at the FDA: In the CDER town hall meeting, Gary noted that FDA...

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GlobalSubmit Exhibiting at DIA Annual Meeting in San Diego

The DIA Annual Meeting will be held in San Diego June 20-25.  If you are attending and we haven’t met yet, I’d love to meet you!  Look for me in our booth, 923 (get your badge scanned to enter a drawing for our extremely cool giveaway – I’m not going to reveal what it is).  I’ll be joined in the booth by my collegues and well-known industry experts Jason Rock and Rahul Mistry. I’ll also be in some...

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Economic Downturn Doesn’t Slow eCTD Adoption

DIA held the 22nd annual Doc Management meeting in Philadelphia the week of February 9th.  Attendance at the conference was good.  I talked with colleagues from many different sponsor companies and vendors – both folks I already knew and new acquaintances.  I was interested and encouraged to hear that most are seeing progress in eCTD adoption, despite the recent economic downturn. On “Regulatory Day”, we heard from a...

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Updates on eCTD Specification in Europe, Japan

EMEA and PMDA provided an update on eCTD status at the traditional “Update on Regulatory Authority Experience” session. Tim Buxton was the speaker from EMEA. He provided the following statistics on eCTDs received between July and December 2007: Centralised Procedure: 14 new applications, 80 variations National Procedures (as reported by national compentent authorities): 659 new applications, 611 variations Mr. Buxton also...

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Japan Reports Progress in eCTD Submissions

eCTD readiness in Japan has always been more challenging than in other regions due to issues with tools handling Kanji characters among other reasons. However, Kiyohito Nakai, Priority Review Director at PMDA, was able to report substantial progress in a February 7th presentation at the DIA Doc Management conference in Philadelphia. To date, Japan has received a relatively small number of eCTDs. To date, they have received: Original...

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