one month: submit trial design
2 more months: FDA says OK
1 more month round up guineea pigs for trial
6 more months : trial
3 more months: examine results
2 more months: file nda
??? more months approval
or were they called off because the FDA minutes are being released this week?
or a couple of weeks later when the checks cleared?
"The New York Times reported earlier this year the FDA asked the Federal Trade Commission to investigate..."
FDA-2013-P-0703 Center for Lawful Access and Abuse Deterrence Abuse-Deterrent Opioids Drug Citizen Petition (505(q) Certification) 6/11/2013 Pending
Under FDC Act § 505(q), which FDA has interpreted to apply only to certain petitions submitted to the Agency after September 27, 2007, “[FDA] shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted.” FDA may not extend the 180-day period “for any reason,” including consent of the petitioner, and may summarily deny a petition submitted with the primary purpose of delaying ANDA or 505(b)(2) application approval.
FDC Act § 505(q) does not apply to all citizen petitions. Excluded from the new law are petitions that relate “solely to the timing of the approval of an application pursuant to subsection (j)(5)(B)(iv)” (i.e., 180-day exclusivity), and petitions that are made by an ANDA or 505(b)(2) sponsor “that seeks only to have [FDA] take or refrain from taking any form of action with respect to that application.” Petitions subject to FDC Act § 505(q) must include a specific certification identified in the new law, and petition supplements and comments must include a specific verification statement. FDA Law Blog vigilantly follows 505(q) petitions and our FDC Act § 505(q) Citizen Petition Tracker has been a big hit. (It beats wading through Regulations.gov to find a particular citizen petition or FDA petition response.)
it was submitted June 11, 2013.
I think it's 180 days....so roughly Dec 11. response...????????
I'll check the response time