Artificial intelligence (AI) and machine learning (ML) tools offer an ultra-material-sparing approach to accelerate ...

The CNPV pilot program reduces review times from 10-12 months to 1-2 months, benefiting generics and biosimilars. Companies must align market access, manufacturing, and post-approval readiness with ...

This session will explore best practices for sourcing and managing comparator products in clinical trials. It is designed to ...

The emerging prevalence of digitalization is a key topic for manufacturers handling excipients. Digital transformation and ...

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

When we do things like quantum calculations, we look at the confirmer space. So what that does is give us insight into how a ...

The program, which utilizes a "collaborative tumor board style review process" and a "multidisciplinary team-based evaluation," offers the benefit of reducing application review times from the ...

In particular, Konagurthu says, AI/ML can help sift through a field of drug candidates in which the percentage that are ...

To meet rising demand, developers of precision radiopharmaceutical therapies must overcome challenges in global isotope ...

The CNPV program aims to reduce drug review times to 1-2 months, raising concerns about safety and regulatory scrutiny. Critics argue that accelerated timelines may lead to safety issues and strain ...

In September 2025, the European Commission (EC), together with the Heads of Medicines Agencies (HMA) and the European ...

Mechanistic models and hypothesis-driven strategies generate optimized efficient solutions for drug development, says ...