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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.
“By incentivizing coordination, we can empower patent examiners and in turn boost competition, including for prescription drugs,” said Sen. Dick Durbin (D-Ill.).
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
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
The agency said it believes that the existing regulations balance “the need to incentivize the development of drugs for rare diseases and conditions with the need to provide patient access to orphan drugs.” Read More