Pediatric Exclusivity: Evolving Legislation and Novel Complexities within Pediatric Therapeutic Development

Annals of Pharmacotherapy

Volumn 48, Issue 3, 2014, Pages 369-379

  Rivera, Donna R ^a   Hartzema, Abraham G ^a  

^a UNIVERSITY OF FLORIDA   (United States)

Author keywords

FDA Amendments Act of 2007; labeling change; patent extension; pediatric drug efficacy; pediatric drug safety; pediatric exclusivity

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALLYLAMINE; ARIPIPRAZOLE; ATORVASTATIN; BIGUANIDE; BISPHOSPHONIC ACID DERIVATIVE; CORTICOSTEROID; DOBUTAMINE; ECHINOCANDIN; EMOLLIENT AGENT; ESOMEPRAZOLE; EYE DROPS; FLUTICASONE PROPIONATE PLUS SALMETEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMMUNOMODULATING AGENT; INSULIN; INSULIN GLARGINE; MONTELUKAST; OLANZAPINE; OXAZOLIDINONE DERIVATIVE; PROTEINASE INHIBITOR; QUINOLONE DERIVATIVE; RETINOID; RNA DIRECTED DNA POLYMERASE INHIBITOR; STEROID; SULFONYLUREA; THROMBIN INHIBITOR; TRIAZOLE; UNINDEXED DRUG; VALSARTAN;

ACT; AGING; ASTHMA; ATTENTION; ATTENTION DEFICIT DISORDER; CHILDHOOD DISEASE; CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; DRUG LABELING; DRUG LEGISLATION; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; FUNDING; GASTROINTESTINAL DISEASE; HEALTH CARE POLICY; HUMAN; HYPERTENSION; LAW; PATENT; PEDIATRICS; PHARMACOECONOMICS; PRIORITY JOURNAL; RESPIRATORY TRACT ALLERGY; REVIEW; SKIN DISEASE;

FDA AMENDMENTS ACT OF 2007; LABELING CHANGE; PATENT EXTENSION; PEDIATRIC DRUG EFFICACY; PEDIATRIC DRUG SAFETY; PEDIATRIC EXCLUSIVITY;

ADOLESCENT; CHILD; CLINICAL TRIALS AS TOPIC; DRUG INDUSTRY; DRUG LABELING; DRUG THERAPY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; DRUGS, INVESTIGATIONAL; HUMANS; LEGISLATION, DRUG; PATENTS AS TOPIC; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896844985     PISSN: 10600280     EISSN: 15426270     Source Type: Journal    
DOI: 10.1177/1060028013514031     Document Type: Review

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