Implementing Minor Changes is Hard to Do Under Variations Regulation
This article was originally published in The Gold Sheet
Executive Summary
European generic drug makers say that it is difficult to implement Type IA changes under the variations regulation because of all the paperwork involved in submitting these changes to competent authorities. A 26 percent fee hike in filing variations is also making it more costly and difficult for manufacturers to justify making changes.
You may also be interested in...
Minor Changes Still Burdensome to Report Under Revised Variations Regulation, European Industry and Competent Authorities Complain
Teligent Slammed By FDA Warning Letter
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
FDA Slams Teligent For Lax Approach To Complaint Handling And Stability Testing
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: