Parents for Orphans
A new guideline details basic requirements for submitting a successful application for a proposed orphan drug in the European Union.
European Change Is Still in the Air
With the impending expansion of the EU and the revamping of current policies, the pharmaceutical industry is on edge, wanting to know what the future holds.
Tightening Up European Pharmacovigilance
To help protect patient safety and cut red tape, the European Union is working to create tougher standards of pharmacovigilance.
Europe Looks at Trials in Future Research
European Parliament debates on the allocation of research funds reveals Euro-MPs views of clinical research in medicines development.
Thinking Ahead on Clinical Research
A high-level group explores ways to support EU pharmaceutical industry research without too much cost to the EU health agencies that pay for medicines.
EU Drafts Research Guidance for Diabetes Treatment
The EU?s Committee for Proprietary Medicinal Products describes the process clinical investigations should follow.
EU Proposes Authorization Changes
Patients, research companies, and regulatory authorities may all benefit from proposed changes to current pharmaceutical legislation, but the proposals will provoke much debate.
The EMEA Keeps Up-to-Date
The EMEA updates its positions on placebos, Crohn?s disease trials, and postmarketing surveillance of drugs used by pregnant women.
