Unlock the potential of high-purity methylcellulose in biotech. Join our upcoming webinar to explore how METHONOVA™ enhances ...
AI transforms formulation, bioanalysis, and manufacturing; accelerated FDA reviews demand parallel development readiness; new nasal spray enhances patient drug access. In this PharmTech video feature, ...
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.
In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried ...
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 ...
The emerging prevalence of digitalization is a key topic for manufacturers handling excipients. Digital transformation and ...
This session will explore best practices for sourcing and managing comparator products in clinical trials. It is designed to ...
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 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 ...