Wednesday, July 24, 2013

Complete Response Letters are received by 42% of NDAs/BLAs, leading to approval delays of up to 26 months.

We're pleased to announce a new content partnership with Datamonitor Healthcare. Each week they’ll be sharing their latest research and insights into the Biosimilars field!

The last thing you want to receive when developing a new drug is a Complete Response Letter. What usually comes to mind when receiving a CRL? Costly delays. So what exactly can be disclosed from a CRL? And who can view it?

Want to learn more? View the complete study conducted by Datamonitor on the trends of approval successes and delays associated with CRLs.

Analysis of several case studies revealed key lessons that could be of relevance to avoiding CRLs with other NDAs/BLAs. These were:

 • Increase investment in manufacturing divisions to ensure that sites are ready for and can pass FDA inspections.
• For BLAs submitted under 351(k) or 351(a), source the reference product from the US for the purposes of comparability.
 • Fully disclose all data available that could be of relevance in the FDA’s drug benefit-risk assessment.
 • Maintain independent source documentation of data that are transmitted via electronic patient-reported outcomes.
• Retain electronic data copies for audit trails: Portable Document Format (PDF) copies alone are not sufficient.
 • Perform a thorough quality check of the entire NDA/BLA to correct all errors or omissions before submission.

To learn more about how CRLs impact the development of Biosimilars join us October 15-17 in Boston, MA for the 14th Annual Business of Biosimilars Conference. For more information, view our agenda. We look forward to seeing you this fall!

Share this article with your social network, just click below to share now!

No comments :

Post a Comment