On September 19th, 2011 the FDA announced a revision to its 2006 guidance titled “Marketed Unapproved Drugs-- Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs” (CPG 440.100). This revised guidance clarifies that any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.
Custopharm can assist with filing ANDA's and NDA's. We filed the 1st eCTD ANDA in 2004, have filed over 100 ANDA's since, approved for the Electronic Submission Gateway (ESG) in 2008, responded to over 100 deficiencies in 2010. Custopharm will make you feel comfortable knowing that your submission is of the highest quality.
Custopharm can also assist with Drug Listings, Establishment Registrations, and SPL filings.
Best,
Dave McCleary
dmccleary@custopharm.com
As the title illustrates this article will apply mainly to ANDA approval times since currently there are no PDUFA or User Fees for generic drug products. Even when and if the user fees reach generics there is no assurance that they will work the same way as they do for NDAs with action dates that are essentially adhered to.
During product development and submission preparation. everyone is familiar in at least some regard with the use of Gantt charts as a project management tool. Gantt charts are a great tool to track and plan in-house or contracted activities for which the sponsor has at least some direct control. Additionally, most Gantt charts I have seen go on to predict expected dates for FDA application acceptance, deficiencies and approval times. However these times were essentially based on empirical evidence or examples that is outdated due to ever changing conditions at the FDA.
We have divided the FDA review process into four main areas; FIFO cue time, review time, deficiency response time and approval time. Everyone's target is to get to the approval time as quickly as possible, however to get there it is essential to manage the three other phases as effectively as possible. Today I will address the FIFO Cue time.
The FDA operates most applications in a First In First Out procedure or FIFO. There are some exceptions such as expedited application or products on the drug shortage list. However, those are out of the scope of this discussion. Our definition of FIFO cue time is the time your submission sits around waiting for it to be picked up for review.
There are not many things that an individual can do to improve the FIFO cue time for a filing since, it is a general issue that effects all companies. The only things that you as an individual company can do to improve your cue time is to get your submission in the cue as quickly as possible. This means filing the submission earlier and ensuring that your company is using the Electronic Submission Gateway (ESG) to submit your filings.
Beyond these two things, the only ways to improve FIFO cue time is to have fewer submissions enter the FDA (which we all know isn't going to happen) or for the industry as a whole to submit higher quality filings that actually have a single cycle approval process. The key contributor for long FIFO cue times are applications that are essentially stuck in the system. By this I mean filings that have received multiple rounds of similar deficiencies and are not prepared in a manner that is easy to review. Typically these submissions are filed by companies that are not familiar with FDA processes or do not place emphasis on regulatory.
To improve this the industry needs to start looking at the regulatory function as an integral part of the product development process. Submitting an application to the FDA is much more than just following guidance documents and providing the data to the FDA. THe process is based on experience from previous applications, working with reviewers, and providing the information to the FDA in a logical easy to follow pattern. Keep in mind that each additional deficiency cycle add months to your product launch date.
Custopharm assists our customers with potential problems they may have when importing pharmaceuticals to the US.
Last month we assisted a customer with a shipment of product valued over $1M. The FDA held the shipment because of an issue with the Establishment Registration and the Drug Listing.
The problem was solved in 24 hours, the customer was then able to ship the product to their destination.
Custopharm utilized the Electronic Submission Gateway, saved the customer time and money.
Please contact Dave McCleary @ (203) 306-7819 or dmccleary@custopharm.com with any questions.
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
-Custopharm
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.