FDA approves mandatory risk management program for isotretinoin.
Cuzzell
Janice Zeigler
JZ
Genentech, Inc., Savannah, GA, USA.
D000014:Abnormalities, Drug-Induced / Q000209:etiology / Q000517:prevention & control; D016907:Adverse Drug Reaction Reporting Systems; D000075202:Contraindications; D003863:Depression / Q000139:chemically induced / Q000517:prevention & control; D016903:Drug Monitoring / Q000592:standards; D006801:Humans; D015474:Isotretinoin / Q000009:adverse effects*; D007641:Keratolytic Agents / Q000009:adverse effects*; D037141:Mandatory Programs / Q000458:organization & administration*; D018579:Patient Selection; D012308:Risk Management / Q000458:organization & administration*; D013723:Teratogens; D014481:United States; D014486:United States Food and Drug Administration
D007641:Keratolytic Agents; D013723:Teratogens; D015474:Isotretinoin