In Reversal, FDA Will Leave Contractors Out Of GMP Head Counts
This article was originally published in The Tan Sheet
Executive Summary
FDA says it will count only a firm's "direct employees" when determining its compliance deadline under the dietary supplement good manufacturing practices final rule
You may also be interested in...
Globalization Bill Should Link IT Systems Across Import Safety – Stakeholders
Draft legislation to reform FDA's import safety oversight fails to address the agency's urgent need to improve the IT connections between its own divisions as well as with other agencies, drug industry stakeholders say
Keep Record-keeping At Top Of GMP Compliance List – Experts
The first compliance date with the dietary supplement good manufacturing practices final rule comes in less than three months, but industry experts say it is likely many firms are not ready and have not mastered the requirements made by the rule, particularly record-keeping responsibilities
Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing
The dietary supplement good manufacturing practices final rule provides "a very flexible framework for required testing," said Vasilios H. Frankos, director of the dietary supplement programs division for FDA's Center for Food Safety and Applied Nutrition