FDA Vs. The Three-Second Rule
This article was originally published in RPM Report
Executive Summary
FDA’s crackdown on Indian manufacturing facilities continues four years after FDASIA boosted overseas inspection reports. The Warning Letters continue to paint an unflattering picture of practices at some sites.
You may also be interested in...
Culture Clash: FDA Tries to Re-Educate Indian Firms on Processes and Accurate Reporting
FDA has essentially shut down Ranbaxy’s three-year-old facility at Mohali as a source for products for the US market. But Ranbaxy is not alone among Indian firms in its quality product disputes with the agency. There is a significant uptick in activity by FDA in the region in what appears to be a period of intense culturization for the Indian firms into the ways FDA enforces cGMPs and handles on-site inspections.
US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA
The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.
Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?
US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.