FDA Publishes Guidance on the Effects of Drugs on Blood Pressure
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
On May 30, 2018, FDA published draft guidance that provides sponsors with advice on the premarketing assessment of a drug’s effect on blood pressure.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
INTERPHEX 2025: Critical Role of Walk-In Chambers in Bio/Pharma Development and Manufacturing
April 3rd 2025Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, sat down with the PharmTech Group at INTERPHEX 2025 to discuss the design and critical role of walk-in chambers in the bio/pharmaceutical industry.
