EU Generic Approvals Could Accelerate By Two Years With Bolar Changes
Executive Summary
The European Commission's proposed patent reforms could accelerate the approval of generic drugs by two years.
You may also be interested in...
FDA "Compassionate Use" Rule Will Outline Access Options Outside Trials
FDA is developing a rule to describe criteria for a range of ways to offer drug treatment options to patients not participating in clinical trials.
Amarin NDA For CeNeS Morphine Suppository Planned For Second-Half 2002
Amarin expects to file an NDA for the morphine-releasing rectal suppository Moraxen by second-half 2002.
EU To Revise Oncologics Guidelines To Increase Cancer Product Approvals
The European Committee on Proprietary Medicinal Products is considering revisions to its guidelines for oncologic products that would help accelerate the development and approval of anticancer agents.