Barbara J. Evans
- Published in print:
- 2015
- Published Online:
- May 2016
- ISBN:
- 9780231171182
- eISBN:
- 9780231540070
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231171182.003.0007
- Subject:
- Law, Medical Law
This chapter explores special challenges FDA will face when assessing the safety and effectiveness of 21st-century preventive medical products that aim to avert future disease (as opposed to treating ...
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This chapter explores special challenges FDA will face when assessing the safety and effectiveness of 21st-century preventive medical products that aim to avert future disease (as opposed to treating manifest disease). The Food and Drug Administration Amendments Act of 2007 gave the agency important new powers to address these challenges but, to date, the agency has not yet fully tapped these new powers.Less
This chapter explores special challenges FDA will face when assessing the safety and effectiveness of 21st-century preventive medical products that aim to avert future disease (as opposed to treating manifest disease). The Food and Drug Administration Amendments Act of 2007 gave the agency important new powers to address these challenges but, to date, the agency has not yet fully tapped these new powers.
Thomas O. McGarity
- Published in print:
- 2013
- Published Online:
- October 2013
- ISBN:
- 9780300141245
- eISBN:
- 9780300195217
- Item type:
- chapter
- Publisher:
- Yale University Press
- DOI:
- 10.12987/yale/9780300141245.003.0011
- Subject:
- Economics and Finance, Economic History
This chapter explains the drug and device industries, which have always had the freedom to become a diverse and technologically dynamic industry capable of designing and manufacturing a broad array ...
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This chapter explains the drug and device industries, which have always had the freedom to become a diverse and technologically dynamic industry capable of designing and manufacturing a broad array of lifesaving products. The Food and Drug Administration Amendments Act of 2007 (FDAAA) raised user fees for both drug and device manufacturers by modest amounts, and allowed the agency to allocate more of the funds they generated to post-market surveillance of approved drugs and devices. It further empowered the Food and Drug Administration (FDA) to require companies to conduct and complete post-approval clinical studies, and allowed the FDA to impose specific label changes. During the Laissez Faire Revival, however, Congress severely limited the FDA's capacity to perform this vital role by reducing the resources available to its surveillance and enforcement functions, while adding to its responsibilities and demanding that it approve new products and technologies at an impossible pace.Less
This chapter explains the drug and device industries, which have always had the freedom to become a diverse and technologically dynamic industry capable of designing and manufacturing a broad array of lifesaving products. The Food and Drug Administration Amendments Act of 2007 (FDAAA) raised user fees for both drug and device manufacturers by modest amounts, and allowed the agency to allocate more of the funds they generated to post-market surveillance of approved drugs and devices. It further empowered the Food and Drug Administration (FDA) to require companies to conduct and complete post-approval clinical studies, and allowed the FDA to impose specific label changes. During the Laissez Faire Revival, however, Congress severely limited the FDA's capacity to perform this vital role by reducing the resources available to its surveillance and enforcement functions, while adding to its responsibilities and demanding that it approve new products and technologies at an impossible pace.
