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The Justice Department recovered more than $900 million from medical product manufacturers relating to False Claims Act violations in fiscal 2017, down from $1.2 billion in 2016. Read More
In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies and Procedures (MAPP) for agency staff that went into immediate effect. Read More
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A new FDA draft guidance outlines clinical trial designs for treatments of male hypogonadotropic hypogonadism, including enrollment criteria and efficacy endpoints.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A new FDA draft guidance recommends sponsors include new class labeling and prescribing information for combined hormonal contraceptives containing estrogen and progestin.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