FDA Modernizes Biotech Regulation Over The Past 20 Years - From a small laboratory to a highly specialized organization, the FDA has grown with the changing needs of the biotech field - BioPharm

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FDA Modernizes Biotech Regulation Over The Past 20 Years
From a small laboratory to a highly specialized organization, the FDA has grown with the changing needs of the biotech field


BioPharm International
Volume 20, Issue 10

Other important programs launched in recent years are reflected in the following:

Growth in Combination Products

The FDA established the Office of Combination Products in 2002 to manage market applications from a growing number of medical products that combine drugs, biologics, and medical devices.

Concerns about Bioterrorism

In the wake of 9/11, Congress approved legislation to strengthen controls on imported products. The Project BioShield Act of 2004 encouraged the development and regulation of drugs and vaccines to prevent or treat bioterrorist threats, a policy reinforced by additional legislation in 2006. CBER has played a lead role in spurring the development of new vaccines and updating production methods to provide preventives and treatments for infectious diseases and biological attack.

Support for Innovation

The FDA issued the Critical Path report in March 2004 urging novel approaches for bringing new therapies to patients. This launched a major effort to encourage FDA collaboration with the industry to counter a decline in new therapies. In 2006, the agency issued an Opportunities List of a wide range of research and regulatory initiatives with potential to lead to biomedical discovery.

Clearer Product Labels

In 2005, the FDA issued requirements for manufacturers to submit drug labeling in electronic format to the Daily Med data bank. The regulations also revised the format of labeling for human prescription drugs and biological products to include a highlights section, making the information easier to access and use.

Regulators and manufacturers are optimistic that recent discoveries in genomic sciences and molecular biology will create opportunities to develop entire new classes of more effective and less toxic medicines, potentially at low costs. Cooperative efforts to adopt new regulatory models in harmony with the approaches of other cultures and nations may streamline drug development and registration, and accelerate global access to new therapies.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,


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