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Add Pregnant Women, HIV Patients to Clinical Trials, FDA Says (1)

June 6, 2019, 4:07 PMUpdated: June 6, 2019, 7:45 PM

Drug and biotech companies should open up more clinical trials to pregnant women, HIV patients, and other volunteers they’ve historically left out, the FDA has proposed.

A draft guidance announced June 6 from the Food and Drug Administration aims to increase access to the clinical trials used to approve new drugs and biologics by broadening the criteria for who’s eligible to participate. The idea is to test the experimental medicines on a more representative sample of the people who will actually take them once they come onto the market.

Clinical trials typically have rigid inclusion and exclusion criteria to eliminate ...