The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
On May 30, 2018, FDA published draft guidance that provides sponsors with advice on the premarketing assessment of a drug’s effect on blood pressure. The agency states that, because elevated blood pressure in patients can increase risk of stroke, heart attack, and death, the effect of a drug on blood pressure should be considered in a benefit-risk assessment.
The guidance addresses precision of blood pressure measurements, and FDA recommends systemic characterization of a drug’s effect on blood pressure during drug development. The guidance also addresses impact in short-term use of a drug compared to long-term use.
Source: FDA
Telix Enters Agreement with ImaginAb to Purchase Next-Gen Therapeutic Candidates
Published: January 13th 2025 | Updated: January 13th 2025The transaction adds a pipeline of early-stage drug candidates against high-value targets to Telix’s portfolio, along with other novel targets currently in the discovery stage.