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The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
On May 30, 2018, FDA published draft guidance that provides sponsors with advice on the premarketing assessment of a drug’s effect on blood pressure.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
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
