Home / Resources / Regulatory, Ethical and Patient Engagement Considerations for Plain Language Summaries
Regulatory, Ethical and Patient Engagement Considerations for Plain Language Summaries

While there is general consensus within the pharmaceutical industry on the importance of providing plain language summaries (PLS) of clinical trial results to participants and the public as a whole, two of the largest regulatory agencies ― the European Medicines Agency and the Food and Drug Administration ― differ on their approach to the matter.

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