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April 05, 2019
From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.
April 03, 2019
In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.
April 02, 2019
Confidence in the quality systems and scientific competence of the API manufacturing team is essential.
Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.
April 01, 2019
The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.
March 27, 2019
The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.
March 26, 2019
The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.
March 25, 2019
The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.
March 22, 2019
EMA has issued advice to healthcare professionals and patients on the potential increased risk of blood clots in the lungs and death with higher than recommended doses of Xeljanz (tofacitinib) in the treatment of rheumatoid arthritis (RA).
March 20, 2019
The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.