FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Seeks Comments on Rare Allergy Trials

Jan. 4, 2019
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The European Medicines Agency is seeking public comments as it prepares new guidelines for rare allergy clinical trials.

The EU regulators believe they have a lot of work to do as the standard approach to clinical trials for rare diseases may not work well for rare allergies.

 “Given the similarities of allergy and the rather large number of [treatments] that are being currently used, this approach seems inefficient and could be streamlined,” the agency says, in a consultation paper released Dec. 21.

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