Category: Pharmaceutical Blog

read more about Proposed New EU Guidelines on Stability Testing Medical Devices

Proposed New EU Guidelines on Stability Testing Medical Devices

According to proposed new EU guidelines  which seek to amend current Directive 2001/83/EC on Medical Devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, it is suggested that there will be increased requirement for evidence of stability testing medical devices. Manufacturers of Medical Devices … Continued


read more about New FDA Stability Storage Guidelines
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New FDA Stability Storage Guidelines

The FDA have issued a New Stability Guidance document earlier this month for ANDAs which now requires stability data on three batches to be generated as opposed to one batch which was the case up to now. Over the past few years, the Office of Generic Drugs (OGD) has received numerous inquiries about what stability … Continued