Clear positives for industry It seems the agency is implementing few changes going forward which make the process of drug development easier below are some of the proposed changes.
“Clear positives for industry
For the biopharma industry, there are quite a few new timelines and pilot programs that may make the process of working with the FDA and developing new drugs that much easier.
For instance, while the usual 10 months for a review of a standard new drug application and 6 months for priority application still stands (and the FDA has to complete its reviews of 90% of applications in that timeline), the FDA now has to provide information on post marketing studies 8 weeks before a sponsor’s PDUFA date, providing even more time for sponsors to get started. Meanwhile, sponsors can also now submit a request to release or cancel a post marketing study, which they can do with a summary of their rationale for why an existing post marketing requirement is no longer necessary.
The commitment letter also spells out more of the details behind the various pilot programs that the agency will establish over the next half-decade.
FDA’s STAR (Split Real Time Application Review) pilot program will conduct reviews earlier than would otherwise occur, potentially leading to earlier approval for qualified efficacy supplements related to already approved therapies. While not exactly an extension of the FDA’s Real Time Oncology Review program, which has dealt with full applications and not just supplements, the STAR pilot seems like an extension of RTOR.”
https://endpts.com/next-user-fee-deal-reveals-where-industry-won-at-the-negotiating-table-with-fda/