FDA issued
the most recent FDA
Data Standards Catalog v4.5.1 dated August 31, 2016 to detail the “Supported and Required Standards”
including standard versions, implementation dates and links to regulatory
references. A few of the key deadlines that will affect our clients in the near
future are as follows:
As of May 5, 2017, all NDA, BLA, ANDA and master file submissions to CDER and CBER must be in the International Council for Harmonisation (ICH) Electronic Common Technical Document (eCTD) format.
Electronic Submission in ICH eCTD Format
As of May 5, 2017, all NDA, BLA, ANDA and master file submissions to CDER and CBER must be in the International Council for Harmonisation (ICH) Electronic Common Technical Document (eCTD) format.
Animal
Datasets
The DSC specifies that any animal data submitted to an NDA, BLA, ANDA, master file or IND must be in the Standard for Exchange of Nonclinical Data (SEND) format for the following submission types:
1)
For NDAs, ANDAs, BLAs, and master files implementation began
12/17/2016.
2)
For commercial INDs, implementation begins 12/17/2017.
Clinical
Datasets
Identical implementation dates to those for animal data are in effect for STDM and ADaM.
Contact RPI to ensure your
readiness to meet FDA’s forthcoming requirements.