Accelerating Drug Development - Pharmaceutical Technology

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Accelerating Drug Development
FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.


Pharmaceutical Technology


Testing and analysis. FDA also supports efforts to understand more fully how nanotechnology may contribute to the development of new treatments. FDA is collaborating with NIST and the National Cancer Institute Nanotechnology Characterization Laboratory to develop characterization assays and methods for preclinical and early clinical testing of such products as a way to better understand their promise for providing more effective and less toxic cancer therapies. FDA has established a Nanotechnology Task Force and Nanotechnology Interest Group of review scientists with expertise in this area to provide input on product development.

And, as part of efforts to prevent the spread of transmissible spongiform encephalopathy, or mad cow disease, FDA scientists are collaborating with colleagues in other government agencies, academia, and industry to develop and assess technologies able to identify prion contamination of biological products. Such tests could be valuable in ensuring the purity of biotechnological manufacturing processes, as well as for screening blood and tissue.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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