IDMP standards aim to improve medicinal product data management but have faced delays, limiting their benefits for the life ...

The CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried ...

Dr. Eva-Maria Hempe, NVIDIA, looks back at 2025 and ahead to 2026, noting that AI accelerates pharma overall, particularly in ...

George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and ...

In Episode 30, John Androsavich, Benjamin Fryer, and John Wilkerson go behind the headlines. Behind the Headlines examines ...

Britton Jimenez, SVP of Sales and Marketing at Codexis, explains how the ECO Synthesis® Manufacturing Platform overcomes the ...

Jonathan Haigh, Head of UK Sites, FUJIFILM Biotechnologies, explores how advanced technologies are being used to reduce risk ...

A long-term, trust-based CDMO partnership can support cell and gene therapy developers from early process development through ...

The European Union (EU) reform establishes a regulatory data and market protection period of eight years, capped at 11 years ...

When referring to this article, please cite it as Hennessy, M. How Innovation and Risk Management Are Reshaping Modern Drug ...

Counterfeit pharmaceuticals jeopardize public health worldwide, often leading to ineffective or dangerous treatments. Enter ...