Government advisers recommended against setting specific requirements for the reliability of new hormonal contraceptives on Wednesday, saying that might keep useful approaches off the market.The panel did recommend, however, that the Food and Drug Administration ask drug companies to conduct follow-up studies on some new methods after they go on the market to identify any safety or reliability problems that failed to show up during initial testing.
The recommendations came a day after the panel recommended testing new hormonal contraceptives on women who are more representative of the general population, including, for example, women who are overweight.
The panel also urged that the agency require drugmakers to test any new approaches on smokers, teenagers, women older than 35 and others to get a more realistic assessment of their effectiveness and risks.
Source: sfgate.com
Tags: Follow-ups | urged | testing | reliability | Panel | HORMONAL | drug | BIRTH | Washington | Health
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