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.
Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.
Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates
US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: