But here is the uncomfortable truth that seasoned regulatory professionals already know and that ambitious founders are ...

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of ...

The FDA’s Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 6 to 3 that AstraZeneca has not demonstrated its oral ...

Predetermined Change Control Plans, Lifecycle Expectations, and New Transparency Obligations - The FDA has been steadily laying ...

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of ...

Two members of Mexican President Claudia Sheinbaum's party in the northwestern Sinaloa state said they would temporarily step ...

For pharmaceutical and life sciences companies ready to embrace this moment, the 10 principles aren't a burden. They're a ...

Expert insights on QMSR compliance: transition steps, gap assessments, risk-based approach, and global harmonization with ISO ...

Rare disease research operates under conditions of extreme complexity. These pressures are driving new approaches to evidence ...

Researchers at the Institute of Science Tokyo have developed a simple and efficient method for synthesizing ...

AI governance is not merely a regulatory requirement, but also the strategic infrastructure that enables sustainable ...