Three Decades of Drug Regulation and Legislation - Pharmaceutical Technology

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Three Decades of Drug Regulation and Legislation
The US Food and Drug Administration has pursued many new initiatives since 1977. The agency began accepting abbreviated applications for generic versions of drugs, collected user fees to support drug review, launched the Critical Path Initiative to encourage innovation, and worked to harmonize its regulatory standards with those of Europe and Japan. New challenges such as AIDS and bioterrorism have affected regulatory policy in recent years. The author reviews FDA's changes in policy and philosophy during..


Pharmaceutical Technology


Despite proposals that threaten to increase the cost of drug development, regulators and manufacturers are optimistic that recent discoveries in genomic sciences and molecular biology create opportunities to develop entirely new classes of more effective and less toxic medicines, potentially at more affordable costs. Cooperative efforts to adopt new regulatory models in harmony with other nations' approaches have the potential to streamline drug development and registration, and accelerate global access to new therapies.

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

Where were you 30 years ago?
"Thirty years ago, I had just come to Washington, DC from New York, where I started my career as a business reporter for a division of Prentice-Hall. As a journalist in the nation's capital, I quickly became educated about government acronyms and Capitol Hill procedures, which provided the background necessary to become Pharmaceutical Technology's Washington editor years later."


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