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Drug Certification

NEWS
December 22, 1990 | VICTOR F. ZONANA, TIMES STAFF WRITER
Trapped in the cross-fire between scientists, drug companies and certain AIDS activists, Dr. Ellen Cooper, the U.S. Food and Drug Administration's top AIDS drug regulator, has requested a transfer to a less-pressured post within the agency. Cooper refused to comment on the move Friday, but friends, associates and an FDA spokesman confirmed her decision to step down. Many said her departure from her post as director of the FDA's Division of Anti-Viral Drug Products in Bethesda, Md.
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NEWS
September 15, 1989 | From a Times Staff Writer
A former generic drug company executive was fined $250,000 and ordered to serve 60 days of an 18-month jail sentence after pleading guilty to bribing Food and Drug Administration officials, the U.S. attorney in Baltimore announced Thursday. Dilip P. Shah, 43, a founder and former president of Quad Pharmaceuticals Inc., also was ordered to devote 12 months of full-time community service to the American Cancer Society.
NEWS
July 29, 1995 | From Associated Press
A Food and Drug Administration advisory panel declined Friday to recommend approval--or disapproval--of a cheaper, generic version of the nation's most prescribed drug, saying it doesn't have enough information. The committee concluded there was "insufficient data" to determine if a generic estrogen drug had to contain all of the components that are in the top-selling Premarin, a hormone-replacement drug used by about 9 million post-menopausal women.
BUSINESS
January 12, 1994 | DAVID R. OLMOS, TIMES STAFF WRITER
The Food and Drug Administration has approved a popular prescription arthritis drug for marketing as an over-the-counter pain reliever--a move that will cause competitive headaches for the makers of Advil, Tylenol and other pain remedies. The drug, naproxen sodium, is the first non-prescription pain reliever to win FDA approval since ibuprofen a decade ago.
NEWS
September 11, 1989 | MARLENE CIMONS, Times Staff Writer
Two generic drug companies already immersed in bribery charges have more pervasive problems than originally thought, and the companies likely will be investigated by the Justice Department's criminal division, two key members of Congress say in documents to be made public today. An admitted bribery payment to Food and Drug Administration employees "appears to be only the tip of the iceberg in a story . . . rife with problems," according to statements by Reps. John D. Dingell (D-Mich.
NEWS
September 28, 1991 | MARLENE CIMONS, TIMES STAFF WRITER
The Food and Drug Administration on Friday approved a new drug to treat a serious AIDS-related infection that often results in blindness. The drug, foscarnet, was approved to treat cytomegalovirus retinitis, an eye infection that can cause blindness in people with weakened immune systems. CMV retinitis afflicts an estimated 46% of AIDS patients who have reached the latter stages of the disease, the FDA said. It is the second drug to be approved for the condition.
BUSINESS
August 25, 1998 | From Bloomberg News
Monsanto Co. said its much-anticipated painkiller, one of a new class of drugs with multibillion-dollar sales potential for conditions such as arthritis, will get a faster-than-usual review by the Food and Drug Administration. The priority review designation generally means that the FDA will decide whether to approve the drug within six months instead of a year. Monsanto, which expects to complete a merger with American Home Products Corp.
NEWS
August 29, 1989 | MARLENE CIMONS, Times Staff Writer
The Food and Drug Administration, escalating its campaign against generic drugs that it believes have been marketed improperly, announced Monday that it will withdraw approval of the last remaining generic equivalent of Dyazide, a leading blood pressure drug. The FDA said it could no longer be certain that Bolar Pharmaceutical's generic drug, one of the nation's best-selling generics, is precisely equivalent to Dyazide.
NEWS
September 12, 1989 | MARLENE CIMONS, Times Staff Writer
The Food and Drug Administration told members of Congress on Monday that investigators gave a clean bill of health to only two of a dozen generic drug manufacturers specially targeted for investigation.
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