title: Accessing FDA approval packages and briefing documents.
authors.forename: Joseph
authors.initials: J
authors.lastname: Ohmer
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Miller
authors.forename: Larry D
authors.initials: LD
authors.lastname: Sasich
mesh_terms: D004282:Documentation; D017277:Drug Approval; D005998:Glycine / Q000031:analogs & derivatives; D048628:Ketolides; D010080:Oxazoles; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D048628:Ketolides; D010080:Oxazoles; C106791:telithromycin; D005998:Glycine; C500085:muraglitazar