GDUFA Implementation Will Be Overseen By Mylan’s Representative in the House
This article was originally published in RPM Report
Executive Summary
Mylan played a pivotal role in crafting the formula to create Generic Drug User Fees. The selection of Rep. Tim Murphy (R-Pa.) to chair the House Energy & Commerce Oversight Subcommittee should help assure that Mylan’s perspectives continue to play an important role.
You may also be interested in...
Mylan’s EpiPen Recall: Another Hit On The Auto-Injector
What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.
Mylan’s EpiPen Recall: Adding Insult To An Injured Product
Pricing controversy around the product got the CEO hauled before Congress; now what began as an overseas recall of one lot made by a Pfizer subsidiary threatens to besmirch Mylan’s once golden supply chain quality record.
Culture Clash: U.S. 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.