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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
A new FDA draft guidance outlines clinical trial designs for treatments of male hypogonadotropic hypogonadism, including enrollment criteria and efficacy endpoints. Read More
The Drug Enforcement Administration proposed listing unscheduled fentanyl products as Schedule I controlled substances to help address the opioid crisis. Read More
A new FDA draft guidance recommends sponsors include new class labeling and prescribing information for combined hormonal contraceptives containing estrogen and progestin. Read More
Kmart agreed to pay a $32.3 million settlement over charges that its in-store pharmacies failed to report discounted drug prices to federal programs and, therefore, were reimbursed at inflated prices. Read More