title: The domestic drug regulatory process: why time is of the essence.
authors.affiliation: Food and Drug Administration, Bethesda, MD.
authors.forename: R
authors.initials: R
authors.lastname: Katz
mesh_terms: D000818:Animals; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D000927:Anticonvulsants