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Global drug spending will climb to $1.5 trillion in the next five years, marking a nearly 32 percent increase, fueled largely by new medicines and emerging markets. Read More
The European Medicines Agency made several changes to a guidance explaining the agency’s policy for publishing clinical trials data and factors that could lead to rejection. Read More
CBER released a set of guidance topics that the center is considering for development this year, covering blood and blood components, tissues and advanced therapies, and chemistry, manufacturing and controls changes. Read More
Drug manufacturer Warner Chilcott was handed a Form 483 after an inspection revealed inadequate written procedures and deficient cleaning and maintenance of equipment. Read More
HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even if the samples were presented with no personally identifying information. Read More
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by the end of September. Read More
The FDA updated its guidance for botanical drug development to include recommendations for navigating combination drug regulations, with possible criteria for receiving a waiver. Read More
The EMA published a third revision to its guideline for human normal immunoglobulin for intravenous use, covering biological data, pharmacokinetics, clinical trials and patient follow-up, as well as changes in the manufacturing process of previously authorized products. Read More
An FDA advisory committee recommended clinical trial endpoints for evaluating treatments of men with hypogonadism while maintaining or improving testicular function. Read More
Officials from the FDA and the National Institutes of Health, in cooperation with public, private and industry stakeholders, published a framework for defining the levels of evidence needed to support the regulatory qualification of biomarkers for drug development. Read More