The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.
Biopharma employees report gains in compensation and job satisfaction, as industry growth continues.
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
Trends and best practices for the use of outsourcing serivces, pricing models, contract manufacturing, facility development and location activities, and clinical trial services.
European CDMOs want into the US market, but entry options are limited.
FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.