Document 0636
 DOCN  M9590636
 TI    Kaposi's sarcoma: DOX-SL approval recommended. Clearinghouse, P.O. Box
       6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.
 DT    9509
 SO    AIDS Treat News. 1995 Feb 17;(no 217):8. Unique Identifier : AIDSLINE
       AIDS/95700331
 AB    The Food and Drug Administration (FDA) drug approval committee has
       recommended that DOX-SL be given accelerated approval for treatment of
       AIDS-related Kaposi's sarcoma (KS) in patients who have failed
       conventional treatment. This decision, coming after several votes
       against the drug's approval, brings up an ongoing problem with the
       current drug-approval system, i.e., the advisory committee for drug
       approvals has developed its own corporate culture for judging approval
       applications that can be disadvantageous to the smaller biotechnology
       company less familiar with the system. In order to prevent mistakes that
       may stop approval of a necessary drug, it may be necessary for the FDA
       to develop a body of knowledge, based on past experience with its
       committee system, to help committee members avoid certain perennial
       mistakes in drug approval.
 DE    Acquired Immunodeficiency Syndrome/*COMPLICATIONS
       Doxorubicin/*THERAPEUTIC USE  *Drug Approval  Human  Sarcoma,
       Kaposi's/*DRUG THERAPY/ETIOLOGY  NEWSLETTER ARTICLE

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       protected by Copyright Law (Title 17, U.S.Code).