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The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance. Read More
A federal appeals court has ruled that companies participating in the 340B drug pricing program may restrict discounts to hospitals that use multiple contract pharmacies, handing appellants Sanofi, Novo Nordisk and AstraZeneca a major win in their ongoing fight with HHS. Read More
Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response based on insulin-like growth factor 1 (IGF-1) levels in early-phase trials, the FDA said in a draft guidance released Monday.
The FDA’s Center for Biologics Evaluation and Research (CBER) has released its guidance agenda for 2023, including five planned guidances on tissues and advanced therapies.
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