Wil Helmus schreef op 12 oktober 2018 16:11:
The Difficulties of a CRL
The Datamonitor study casts new light on many of those difficulties. The study looked at 346 NDAs and BLAs submitted after 1 October 2008, when FDA moved away from its "approvable" and "unapprovable" letters to the more descriptive CRLs.
Of those NDAs and BLAs, 281 (81%) received approval from the agency, of which 200 (71%) received approval during the first round of review. The remaining 81 submissions (29%) were approved during subsequent second, third (and beyond) submissions. Earlier studies, such as a 2012 analysis by the industry trade organization BIO, found that subsequent submissions have a far lower rate of approval. Only 1.4% of submissions made after the third round of submissions obtained approval , BIO found.
Complete response letters featured prominently in these reviews, Datamonitor found. One hundred and forty-six (42%) of all submissions received a CRL, of which 55% later obtained approval. Approximately a third of the submissions were withdrawn, while another 16% were still undergoing review by regulators.
The delays caused by these CRLs could in some cases be substantial. The median delay was 13 months for Class 2 (generally major) resubmissions, though those delays could be as short as 3.5 months and as long as 26 months.
Class 1 (generally less serious) resubmissions had a median time of 4.4 months (range = 1.5 to 9.1 months).www.raps.org/regulatory-focus%E2%84%A...