Discovery Groups: The Detectives of Cell Biology

Abstract

Both Industry and the FDA benefit when firms submit acceptable, complete Abbreviated New Drug Applications (ANDAs) which can be processed expediently and culminate in approval. An overview of the mechanics of the ANDA submission and review process is presented, and current problem areas in the submission process are identified. The criteria used in evaluating an ANDA submission in terms of acceptability and completeness are set forth. The ANDA Management Information System used in the tracking of submissions under review in the Division of Generic Drugs is described.     

The Alabama Drug Discovery Alliance: A Collaborative Partnership to Facilitate Academic Drug Discovery

The Alabama Drug Discovery Alliance is a collaboration between the University of Alabama at Birmingham and Southern Research Institute that aims to support the discovery and development of therapeutic molecules that address an unmet medical need. The alliance builds on the expertise present at both institutions and has the dedicated commitment of their respective technology transfer and intellectual property offices to guide any commercial opportunities that may arise from the supported efforts. Although most projects involve high throughput screening, projects at any stage in the drug discovery and development pathway are eligible for support. Irrespective of the target and stage of any project, well-functioning interdisciplinary teams are crucial to a project’s progress. These teams consist of investigators with a wide variety of expertise from both institutions to contribute to the program’s success.