Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012

JAMA

Volumn 311, Issue 4, 2014, Pages 378-384

  Sacks, Leonard V ^a   Shamsuddin, Hala H ^a   Yasinskaya, Yuliya I ^a   Bouri, Khaled ^a   Lanthier, Michael L ^a   Sherman, Rachel E ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; ANTIANGINA PECTORIS AGENT; ANTIASTHMATIC AGENT; ANTICONVULSIVE AGENT; ANTIHYPERTENSIVE AGENT; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; HEMATOLOGIC AGENT; NEW DRUG;

ACUTE DISEASE; ALLERGY; ANGINA PECTORIS; ARTICLE; ASTHMA; BLEEDING; CARDIOVASCULAR DISEASE; COMPARATIVE EFFECTIVENESS; DOSE RESPONSE; DRUG APPROVAL; DRUG CONTROL; DRUG FATALITY; DRUG MARKETING; DRUG SAFETY; DRUG TREATMENT FAILURE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; HEMOSTASIS; HUMAN; HYPERTENSION; IMMUNOPATHOLOGY; INFECTION; INFLAMMATION; KIDNEY DISEASE; LIVER DISEASE; MALIGNANT NEOPLASTIC DISEASE; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; OPTIMAL DRUG DOSE; OUTCOME ASSESSMENT; PAIN; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SEIZURE; UNITED STATES; UNSPECIFIED SIDE EFFECT;

EID: 84892777392     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2013.282542     Document Type: Article

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