Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.
Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.
Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.