Food And Drug Administration U S

Genentech Inc. said the Food and Drug Administration approved use of its Pulmozyme for patients with the most severe form of cystic fibrosis. The drug, already approved for patients with less severe forms of the debilitating disease, helped improve lung functioning even in the most advanced patients, the company said.

Smokers who want to quit but crave nicotine and miss fidgeting with cigarettes may get a new source of help--a smokeless nicotine inhaler they can puff on any time. A federal advisory committee recommended approval of the Nicotrol inhaler Friday as the fourth alternative source of nicotine for people trying to give up smoking. The current options are nicotine patches, chewing gum or nasal spray.

AMDL Inc., a biomedical company, said the Food and Drug Administration asked the firm to withdraw its application to sell a test for a stomach-irritating bacteria until it provides additional clinical data. AMDL's test, PyloriProbe, is designed to detect the presence of H. pylori, which is associated with ulcers. AMDL said additional studies of PyloriProbe are in progress and that it plans to resubmit its application with the FDA. PyloriProbe is only available for distribution outside the U.S.

The Food and Drug Administration nearly doubled the approval rate of new "breakthrough" drugs this year and reduced the review process time by half, outgoing FDA Commissioner David A. Kessler said in his annual "state of the FDA" speech. For the 1996 fiscal year ending Oct. 1, 46 of the drugs were approved, he said, adding that the average review time dropped from 30 to about 15 months.

Patients are not always fully informed that they are guinea pigs in medical research studies authorized by the U.S. Food & Drug Administration, a newspaper said. The Plain Dealer of Cleveland said it analyzed FDA files obtained under the Freedom of Information Act and found that in 4,154 inspections of researchers testing new drugs on humans, the FDA cited more than 53% for failing to fully disclose the experimental nature of their work.

Federal regulators in Gaithersburg, Md., issued an unusually strong warning to stop eye doctors from using unapproved laser surgery machines to correct nearsightedness. The warning is the latest in a blitz of controversy over a popular laser surgery that promises better vision without glasses to many of the 60 million Americans who are nearsighted. The FDA has approved two lasers since last fall, made by Summit Technology and Visx, to help people see more clearly at a distance.

Clearing a path for revolutionary changes in the way American women undergo abortions, a federal advisory committee Friday recommended that the Food and Drug Administration approve RU-486, the controversial French abortion pill, for use in the United States. An overwhelming majority of the eight-member panel endorsed the decision that the drug is safe and effective and that its benefits outweigh its risks.

Moving with unusual speed, the Food and Drug Administration on Friday announced full approval of a powerful new AIDS drug that has been shown to reduce episodes of illness and prolong the lives of very sick patients. The licensing of ritonavir comes a scant 24 hours after an FDA advisory committee recommended that the drug be approved for use only in advanced cases of the disease.

The federal government will take new measures to speed up release of promising experimental cancer drugs to the public, a move expected to shave years from the often-lengthy process, President Clinton said Friday. "There is hardly a family in America who has not been touched by cancer," said Clinton, who lost his mother and stepfather to the disease. "We have come a very, very long way in the fight against cancer. More people are survivors than ever before. But we have a great deal more to do."