NSF Health Science has release five white papers on 510(k) requirements for extractables and leachables; analytical challenges for leachables; FDA excipient regulations; quality in the US pharma industry and new European regulations for medical devices.
The five white papers are as follows:
- Extractables and Leachables for Medical Devices: Meeting the 510(k) Requirements
- Analytical Challenges Presented by Leachables from Sample Container Closure Systems in Drug Products
- FDA is Increasing Regulations on Excipients Worldwide – What Can Your Company Do to Reduce Risk?
- What Will Eventually Wake Up the US Pharma Industry to the Importance of Quality; the Stick, or the Carrot?
- Proposed New European Regulation for Medical Devices to Replace 93/42/EEC and 90/385/EEC
These free white papers can be downloaded here.