Was just browsing through some information available on the FDA...

Was just browsing through some information available on the FDA website in relation to guidance updates, changes and compliance issues etc, with pain medications through the CDRH/FDA channels, such as these following links - Efficacy of Opioids in the Treatment of Patients with Chronic Pain – Limitations of the Research - FDA Downloads 2012 and Efficacy Conclusions in Recent Treatment Guidelines - FDA Downloads 2012

But then stumbled across the following NDA consultation summary (linked below) between the FDA and a US based pharmaceutical manufacturer seeking NDA approval for an Oxycodone Hydrochloride Oral Solution. Perhaps I'm missing something here, but as I see it the company requested a 3 year exclusivity period without providing any efficacy studies or clinical data... However, the manufacturer does claim that the 'packaging' for this new immediate release Oxycodone tablet is, (drum-roll here)... "child proof"

One can't help but question motives behind some regulatory decisions when a company like QRX get knocked back having invested millions of dollars into R&D programs and regulatory filings supported by successful clinical data for product innovation incorporating an anti-abuse solution, whilst others offering no new (adult) 'tamper' proof solution, safety, efficacy, nor pre-clinical or clinical data of any kind in support of its own application, have no trouble gaining FDA market approval... generic copy or not, I was under the assumption that the US government were implementing measures to cut opioid abuse?

VistaPharm - Oxycodone Hydrochloride Oral Solution - NDA # 201194

QRX have a high quality experienced team which imo are quite capable of getting past the gatekeeper next time, but I do share stakeholder frustrations in regards to FDA delays...

GL to all.