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The International Council for Harmonization (ICH) has issued the final version of its revised guideline on quality risk management ICH Q9(R1), adding information on risk management methodology, such as assessing the degree of risk analysis required, risk-based decision-making and managing subjectivity.
Sen. Elizabeth Warren (D-Mass.) has asked the Federal Trade Commission (FTC) to take a hard look at two pending pharmaceutical mergers she believes could impact drug prices. Read More
The FDA has pulled the Emergency Use Authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab/cilgavimab) because, the agency says, more than 90 percent of the circulating SARS-CoV-2 variants in the U.S. are now resistant to it. Read More
A bipartisan group of senators has re-introduced proposed legislation to establish a task force between the U.S. Patent and Trademark Office (USPTO) and the FDA to improve coordination in implementing each agency’s work related to patents. Read More
Nearly four dozen pediatric clinical trials involving more than 3,600 children failed to publish their findings on ClinicalTrials.gov or in scientific literature, according to a new analysis by U.K.-based trial transparency advocacy group TranspariMED and other non-U.S. researchers. Read More
The FDA has launched a pilot program to increase the efficiency and predictability of biosimilar development, and decrease the cost and time of development — and has released a “research roadmap” to help researchers reach those goals. Read More
FDA Principal Deputy Commissioner Janet Woodcock announced Thursday that, after careful review, a new regulatory pathway for cannabidiol (CBD) review is needed and the agency is denying three citizen petitions to allow marketing of CBD products as dietary supplements. Read More
An FDA advisory committee yesterday recommended that the next generation of COVID-19 vaccines should combine the current primary vaccine against the original Wuhan strain and the bivalent booster against Omicron strains BA.4 and BA.5. Read More
Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator, and the topline numbers didn’t come with context indicating their statistical validity. Read More