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Marion Gruber

Researcher at Food and Drug Administration

Publications -  16
Citations -  949

Marion Gruber is an academic researcher from Food and Drug Administration. The author has contributed to research in topics: Medicine & Engineering. The author has an hindex of 9, co-authored 12 publications receiving 420 citations.

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Recommendations from the national vaccine advisory committee: Standards for adult immunization practice

TL;DR: While previous versions of the adult immunization standards have been published, recommendations for adult vaccination are published annually, and many health-care organizations have endorsed routine assessment and vaccination of adults, vaccination among adults continues to be low.
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An overview of the regulation of influenza vaccines in the United States.

TL;DR: This review describes the process of licensing influenza vaccines in the U.S., the process and steps involved in the annual updating of seasonal influenza vaccines, and some recent experiences and regulatory challenges faced in development and evaluation of novel influenza vaccines.
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Overview of global regulatory toxicology requirements for vaccines and adjuvants.

TL;DR: An overview of the legislations and regulatory approaches currently applied to the nonclinical safety assessment of human preventive vaccine products in three ICH regions, i.e., the EU, USA, and Japan is provided.