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Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process. Read More
The FDA approved 46 novel drugs in 2017, hitting a two-decade high after approvals plunged in the previous year — a record 53 novel drugs were approved in 1996. Read More
A new FDA draft guidance outlines clinical trial designs for treatments of male hypogonadotropic hypogonadism, including enrollment criteria and efficacy endpoints. Read More