Well, a positive start at least with some direction which is good.
Issue def at the forefront FDA.
2018 report just completed and released this month.
https://www.fda.gov/downloads/Drugs/DrugSafety/UCM629304.pdf
Pages 20-24, liked item 3.
These efforts are congruent with the FDA’s four priority areas for addressing the prescription opioid crisis:• Decreasing exposure and preventing new addiction• Supporting treatment of those with opioid use disorder• Fostering the development of novel pain treatment therapies• Improving enforcement and assessing benefit/risk.
Also, diff in the 505(b) 1 & 2 of which POH is looking at 2 where there can be reliance on some external data.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm
505(b)(1) Application — A 505(b)(1) application is an application that contains full reports of investigations of safety and effectiveness. The investigations the applicant relied on for approval were conducted by or for the applicant or the applicant has obtained a right of reference or use for the investigations.
505(b)(2) Application —A 505(b)(2) application is an application submitted under section 505(b) for which
- Some or all of the investigations the applicant relied on for approval were not conducted by or for the applicant
and
- The applicant has not obtained a right of reference or use for the investigations (21 U.S.C. 355(b)(2))
Section 505(b)(2) expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant, such as published literature or the Agency's finding of safety and/or effectiveness of a previously approved drug product.
(20min delay)
