Pharma ACTD Dossiers

Recently, the FDA declared that it was no longer accepting applications for generic formulations of Oxycontin . The reason? Because Purdue Pharma, OxyContin’s manufacturer, had developed–and received approval for–an “abuse-resistant” formulation of the drug. Whether this is an example of regulatory gamesmanship or the fruits of incentivizing public safety is up for debate. With that in mind, the CLB blog is proud to host a short debate between CLB Fellow, Jake Sherkow, and Duquesne School of Law Professor, Jacob Rooksby. The FDA’s determination is sensible. It recognizes the original OxyContin®’s abuse limitations and the attendant public safety risks of allowing generic versions of the original drug to enter the market. OxyContin® (oxycodone hydrochloride) quickly became the market leader in the burgeoning field of chronic pain management when the FDA approved it for sale in late 1995. Touted for its patented sustained-release properties, OxyContin® a...

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Indian Regulatory system                               Overview                                        Pharma ACTD Dossiers Introduction Geographically, India is comprise area of 3.29 million sq. km. (1.27 million sq. mi.); about one-third the size of the USA. Genetically, culturally and socio-economicallydiverse population base of more than 1.2 billion is a home for a numerous diseases as well as for qualified, English-speaking professionals, Institutions and hub of contract manufacturers and researchers. Today, Indian economy stand as the third largest based on the Purchasing Power Parity (PPP) and in terms of globally eleventh largest by nominal Gross Domestic Product (GDP), due to its rapid growth, especially over the last decade, India is considered an industrialized  nation. Apart from bein...