Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications

• Lin-Chau Chang,

  Affiliation Master of Science in Regulatory Science Program, Advanced Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Rockville, Maryland, United States of America

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• Riaz Mahmood,

  Affiliations Master of Science in Regulatory Science Program, Advanced Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Rockville, Maryland, United States of America, School of Osteopathic Medicine, Campbell University, Lillington, North Carolina, United States of America

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• Samina Qureshi,

  Affiliations Master of Science in Regulatory Science Program, Advanced Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Rockville, Maryland, United States of America, Healthcare/Pharma, PSI International Inc., Fairfax, Virginia, United States of America

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• Christopher D. Breder

  * E-mail: cbreder1@jhu.edu

  Affiliations Master of Science in Regulatory Science Program, Advanced Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Rockville, Maryland, United States of America, Division of Neurology Products (DNP), Office of Drug Evaluation 1 (ODE1), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (USFDA), Silver Spring, Maryland, United States of America

  http://orcid.org/0000-0002-1902-1595

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