FDA will convene a one-day, in-person and virtual public workshop, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine ,” on Tuesday, Dec. 16, 2025 (1). The workshop is ...

Gain leadership and innovation insights from CEO of the Year finalist at 2025 CPHI Pharma Awards, Mahler Hanns-Christian, who ...

The CNPV pilot program significantly reduces review times, but may challenge safety standards and resource allocation.

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 ...

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

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

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle ...

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 ...

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 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 ...