Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: SATURDAY, March 23, 1991 TAG: 9103230223 SECTION: NATIONAL/INTERNATIONAL PAGE: A-10 EDITION: METRO SOURCE: DATELINE: WASHINGTON LENGTH: Short
The FDA's recommendation does not constitute approval of the drug or an endorsement of its effectiveness. Just last week, in fact, an FDA advisory committee recommended against approving the drug for sale because it said the scientific data did not demonstrate it was effective in combating the disease.
Nor do FDA officials currently contemplate making the drug available to anyone who wants it.
Rather, based on recent preliminary suggestions that it may be possible to improve the drug's effectiveness, FDA officials said they now feel it would be worthwhile to open up trials to large numbers of patients under a program known as "expanded access." - Washington Post
by CNB