FDA’s Second Continuous Marketing Application Pilot Program Nearly 50% Enrolled
This article was originally published in The Pink Sheet Daily
Executive Summary
Nine divisions have not yet selected their application for the pilot program, which involves frequent scientific feedback and interactions with FDA during the IND phase of product development. Applications are being accepted through the end of September.
You may also be interested in...
HGS To Focus On "Core Pipeline" As Part Of Cost Reduction Plan; CEO Steps Down
Human Genome Sciences plans to reduce its headcount by 20% and limit the number of drugs in early development. In 2004 and 2005, the company will focus on five products in immunology/infectious disease and oncology.
HGS To Focus On "Core Pipeline" As Part Of Cost Reduction Plan; CEO Steps Down
Human Genome Sciences plans to reduce its headcount by 20% and limit the number of drugs in early development. In 2004 and 2005, the company will focus on five products in immunology/infectious disease and oncology.
Millennium Prostate Cancer Agent Selected For FDA Continuous Marketing Application Pilot
The monoclonal antibody-linked chemotherapeutic MLN2704 is in a Phase I/II study for metastatic androgen-independent prostate cancer.