Recent News/Upcoming Events
July 2011
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 was 31 months in Fiscal Year 2010. This is up from 26.70 in Fiscal Year 2009 and 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 2,300 application mark and is reportedly growing at about 100 applications per month. We understand that the median ANDA approval time is edging closer to 34 months from application submission.
December 2011
CUSTOpharm Announces ESG and eCTD Stats
CUSTOpharm received approval from the FDA to submit via the ESG in May 2008. Since that time 1000+ ESG filings have been submitted using the ESG.
CUSTOpharm filed their first eCTD in 2004. Since that time 100+ filings have been submitted using eCTD format.
CUSTOpharm filed the first eCTD ANDA with the FDA in 2004, we now have over 8 years of experience.
Utilizing the ESG can enable an organization to submit to the FDA without using paper, pressboards or couriers. In addition to less hassle, utilizing the ESG can save organizations valuable resources like time and money. Check out the FDA’s return on investment (ROI) webpage for additional information.
If you would like additional information about the ESG or our eCTD submission services and solutions, please contact us at 760-481-7590 or email busdev@custopharm.com.
March 2012
CUSTOpharm attended the annual Drug, Chemical & Allied Trades Association (DCAT) Meeting at the Waldorf Astoria in NY, NY.
CUSTOpharm is now accepting meeting requests for the conference. If you would like to schedule a meeting time during DCAT, please contact us at 760-481-7590 or email busdev@custopharm.com.
October 2012
CUSTOpharm to attend the Convention on Pharmaceutical Ingredients (CPhI Worldwide)
CUSTOpharm will attend the CPhI Worldwide Meeting (October 8th-11th) in Madrid, Spain. CUSTOpharm is now accepting meeting requests for the conference. If you would like to schedule a meeting time during CPhI, please contact us at 760-481-7590 or email busdev@custopharm.com. For additional information about CPhI visit www.cphi.com.