Word: fda
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...Harley A. Haynes, director of the dermatology division at Brigham and Women's Hospital, said yesterday that studies demonstrate the drug's effectiveness against wrinkles and certain types of pre-malignant lesions, purposes for which it is not approved by the Food and Drug Administration (FDA...
While it is a long-term investment--Repligen does not expect to be able to market the drug until it is approved by the FDA--Ratan projects a potential market of $200 million...
...since THA eased his wife's Alzheimer's symptoms, Rehnquist has been crusading to get the drug into patients' hands -- legally or not. One day he is instructing people on how to smuggle the drug from the Bahamas. The next day he may be speaking, invited or not, at FDA hearings, sending out a barrage of letters and organizing other families to do the same. Later this month Rehnquist will lead a demonstration outside the FDA's offices. "I have to fight for my wife and my daughters," he says, "and all those people who call me and are hurting...
...most profound impact of the advocacy movement has come within the Food and Drug Administration. The agency has for decades held to the rigid standard that new drugs must be unequivocally proved to be both safe and effective. But in the wake of intense lobbying, the FDA will now consider granting conditional approval to experimental treatments for terminal diseases for which there are few or no medical alternatives. This is a radical shift for the nation's pharmaceutical watchdog. Drugs conditionally approved will be closely monitored and withdrawn if they prove to be too toxic or ineffective...
...proposal that has won the tentative backing of both the FDA and the pharmaceutical industry could clear the way to quicker drug approvals. The plan, which is scheduled for congressional consideration in September, would allow the FDA to collect $75 million from drug companies in application and other fees each year for the next five years. Each individual application would cost $150,000. With the money, the agency expects to hire 600 additional reviewers and cut its average approval time for the most important drugs from 12 to six months...