But is bioavailability sufficiently monitored by FDA for generic products on the market?
Dating back to the FDA Safety and Administration Act of 2012 (FDASIA), Congress had taken a more critical look at FDA inspection practices generally, and the specific problem of fewer inspections of manufacturing sites outside the US than inside it. A 2010 GAO report had found that 40% of domestic manufacturers had been inspected, but only 11% had been during 2007-2009 (not all manufacturers have to inspected all the time; and since then FDA has instituted a risk-based evaluation process to target certain sites). Now, HHS' Office of Inspector General has found
Streebo offers a free look at Sunshine Act data compiled by type, company and physician
It hasn't taken long for IT companies serving the pharma industry to make use of the publicly available data on aggregate spending on physicians, an outcome of the Physicians Sunshine Act. One of the first out the gate is Streebo (Houston), a boutique business-analytics and software developer that counts a number of pharma companies (Eisai, Otsuka, Sunovion) among its customer base. Streebo has launched OpenPaymentsAnalytics.com, and is offering free access to qualified pharma employees to peruse the data published on the latter half of 2013 in the CMS Open Payments database, which initially became available last September. Mohammed Ovais, managing partner, says that the 2014
Mevion's compact S250 unit bids to change the economics of radiation oncology
In some circles, proton beam accelerators (PBAs) are looked on as a bad case of overreach by hospital systems scrambling to offer the latest and greatest in cancer care with little regard for health economics or outcomes. Until recently, the devices were massive units costing hundreds of millions of dollars; there are about 25 units in operation or various stages of commissioning across the country, and already there are questions whether the units are cannibalizing each other's base of potential patients
AstraZeneca's Seroquel XR sample kit takes top honors
An annual tradition since 1995, the Healthcare Compliance Packaging Council's Package of the year winner, this year, is a blister-carded 14-day sample kit from AstraZeneca, for its Seroquel XR (extended release quetiapine), an "atypical antipsychotic" for treatment of a variety of mental health conditions. First Runner-Up is Eli Lilly's Strattera (atomoxetine, for ADHD) physician's sample pack, and Second Runner-Up is the Exforge HCT blister package. Novartis' Exforge HCT (amlodipine, valstartan, hydrochlorothiazide) is indicated for high blood-pressure treatment and is taken
Pharmaceutical Commerce sat down with Dahod to talk about DSCSA, the pharma industry's current supply chain management capabilities, and the future outlook of commercial IT management. Here's what he had to say.