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FDA Safety and Innovation Act signed - Establishment Registration and Facility Identifier


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The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, and effective on October 1st, 2012, amends the Act by requiring additional information to be submitted for the registration of domestic or foreign drug facilities.  This additional information includes the unique facility identifier of each drug establishment and a point of contact e-mail address.  Furthermore, as of October 1, 2012, the re-registration period for domestic and foreign drug manufacturers has been changed to October 1st to December 31st of each year, instead of the previously more open-ended period of on or before December 31st of each year.  

Custopharm can assist our customers with this service.

For assistance please call Dave McCleary @ 760 481-7590 or by email

eCTD ANDA Submission Statistics


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FY 2009

•859 ANDAs submitted in FY 2009

•263 PIV submissions

409 eCTD submissions

242 CTD submissions

30 paper CTD submissions

178 Gateway submissions

8 ANDA's RTR's (Refuse to Review) in FY 2009


FY 2010

•813 ANDAs submitted in FY 2010

•262 PIV submissions

119 CTD submissions

271 eCTD submissions

12 paper CTD submissions

411 Gateway submissions

13 ANDA's RTR'd in FY 2010


FY 2011

•853 ANDAs submitted (as of 9/26/2011)

•211 PIV submissions

60 CTD submissions

177 eCTD submissions

5 paper CTD submissions

611 Gateway submissions

•48 ANDAs RTR’d (as of 9/26/2011)


Relevance of numbers

100% of Original ANDAs being submitted are in CTD format (eCTD+paper CTD+Gateway)

Approximately 95% (or more) of original submissions are now electronic

Gateway submissions have continued to surge tremendously

58=(2008) 178=(2009) 411=(2010) 611=(2011)

RTR's as a percent of submissions is about 17% (data is incomplete as all of FY 2011 submissions have not been reviewed)  FY 2008=15%, FY 2009=9%, FY 2010=14%

FDA currently has approximately 2500 ANDA's under review

FDA currently has approximately 4900 CMC Supplements under review 

*All information above from GPhA Technical Conference held in Bethesda, MD - Oct 3-5 Kwadwo Awuah, Pharm D., R.Ph,. Regulatory Support Management Officer, Office of Generic Drugs, FDA


Industry average ANDA approval times are approximately 33 months, industry has done an excellent job converting to electronic ANDA filings from paper.

The focus for industry remains to provide the FDA 'well written' ANDA applications, this will assist the FDA with more efficient review times.

Custopharm filed the 1st eCTD ANDA in 2004, have filed over 100 since.  Custopharm assists companies by through Regulatory assistance, when we fully write eCTD ESG ANDA's the average approval time is significantly faster than the industry average.


Dave McCleary

New eCTD Software Looking for Beta Testers

eCTD LogoA new easy to use eCTD software is entering the final phases of beta testing and we are looking for volunteers to evaluate and provide input crucial to the finalization and completion of the software.

This software is based on the principles that software should be easy to pick up and use and therefore does not require extensive training and is designed to be "Mac" like in its ease of use. However, if anybody needs instructions we are more than happy to help.

Currently, we are looking for volunteers to evaluate the capabilities of the software and make recommendations as to how to improve it.  Ideal beta testers would be regulatory consultants working on a variety of submissions types for the US market; however direct pharmaceutical employees are requested to register as well.  This is a rare opportunity to use an eCTD software package at no cost.

We feel this is the first eCTD software to actually do what software is supposed to do and simplify the process for preparing eCTD submissions.

To be considered as a Beta tester please contact us directly by completing the form.  Once we have made our selections we will advise you that you were chosen and provide instructions regarding the software installation.

ANDA Review Times

There is a growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”).  The median ANDA approval time in Fiscal Year 2009 was 26.70 months.  This is up from 21.65 months in Fiscal Year 2008 and up from 17.3 months in Fiscal Year 2003.  Today, the ANDA backlog has surpassed the 2,000 application mark and is reportedly growing at about 100 applications per month. We understand that the median ANDA approval time is edging closer to 

30 months from application submission.

Companies must submit ‘well written’ regulatory filings.  There is so much effort in compressing development timelines, it is critical to file the most efficient ANDA/NDA/IND possible to compress review times.

If you are

 not filing ‘well written’ regulatory filings it is costing your company time and money.  We have countless examples of how the ‘well written’ Gateway filing improves approval timelines.  

The above statistics are the building blocks to file a superior filing to the FDA, we continually implement what we learn to build a stronger A

NDA/NDA/IND.  When Custopharm fully develops a product there are fewer review cycles with the FDA, each review cycle can cost months of ‘on the market’ time.  Custopharm understands the technical aspect of development.

-Custopharm has filed many IND’s for development companies.

-Custopharm filed the first eCTD ANDA in 2004


 has filed over 90 eCTD ANDA’s

-Custopharm w

as approved for the Electronic Submission Gateway in May 2008, filed over 475 since.

-Custopharm has filed 159 Gateway filings in 2009

-Filed 100+ Gateway filings through May 15th, 2010

-In 2009 Custopharm responded to over 100 deficiencies

Trust your Regulatory filings to Custopharm, a 'well written' ANDA has become more important

 than an efficient development timeline.  More time on the market means more profit in your bottom line. 


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