Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: Cross sectional study

BMJ (Online)

Volumn 350, Issue , 2015, Pages

  Lurie, Peter ^a   Chahal, Harinder S ^a   Sigelman, Daniel W ^a   Stacy, Sylvie ^a   Sclar, Joshua ^a   Ddamulira, Barbara ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHEMISTRY; CLINICAL PHARMACOLOGY; COMPARATIVE STUDY; COMPLETE RESPONSE LETTERS; CONTENT ANALYSIS; CROSS-SECTIONAL STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG FATALITY; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; FACTUAL DATABASE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; LICENSING; MASS COMMUNICATION; PRESS RELEASE; PRIORITY JOURNAL; PROBABILITY; PUBLICATION; LEGISLATION AND JURISPRUDENCE; PRODUCT SAFETY; RESEARCH; UNITED STATES; WRITING;

CONSUMER PRODUCT SAFETY; CORRESPONDENCE AS TOPIC; CROSS-SECTIONAL STUDIES; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; RESEARCH REPORT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84936822892     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h2758     Document Type: Article

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