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FORTI Publications
Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future
Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future
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Professionalism, Politics, Foreign Corrupt Practices, Product Classification, Globalization and the Future
What does the future hold in terms of food and drug regulation? How should FDA regulate tobacco products, food, human and veterinary drugs, biologics, medical devices, cosmetics and dietary supplements? The answer is multifaceted and complex. Yet, the major focus should be that of public protection to uphold the tenets of the Federal Food, Drug and Cosmetic Act. What should FDA focus on in terms of future focus? Cross cutting topics and special issues are de-tailed in this chapter. Counterterrorism remains in the forefront. Globalization plays a key role in the regulation of food, drugs, cosmetics, medical devices and biologics and this chapter high-lights FDA’s role outside of the United States to protect the United States public health from un-safe imported products. Product classification remains complicated. Legal decisions have illus-trated that intended use controls in determining product category. That is, the historical decisions of Line Away and Sudden Beauty still provide judicial guidance on whether the product is a food, drug, cosmetic, medical device, dietary supplement or combination product. The question remains whether product categorization should be revisited to amend the FDCA.
The role of professionalism, ethics, accountability and “corporate governance” remain criti-cal for public trust. FDA has post employment restrictions and there is a statutory application to former employees including a cooling off period. Jurisdiction or the authority of FDA to regulate remains imperative.
What does the future hold in terms of food and drug regulation? How should FDA regulate tobacco products, food, human and veterinary drugs, biologics, medical devices, cosmetics and dietary supplements? The answer is multifaceted and complex. Yet, the major focus should be that of public protection to uphold the tenets of the Federal Food, Drug and Cosmetic Act. What should FDA focus on in terms of future focus? Cross cutting topics and special issues are de-tailed in this chapter. Counterterrorism remains in the forefront. Globalization plays a key role in the regulation of food, drugs, cosmetics, medical devices and biologics and this chapter high-lights FDA’s role outside of the United States to protect the United States public health from un-safe imported products. Product classification remains complicated. Legal decisions have illus-trated that intended use controls in determining product category. That is, the historical decisions of Line Away and Sudden Beauty still provide judicial guidance on whether the product is a food, drug, cosmetic, medical device, dietary supplement or combination product. The question remains whether product categorization should be revisited to amend the FDCA.
The role of professionalism, ethics, accountability and “corporate governance” remain criti-cal for public trust. FDA has post employment restrictions and there is a statutory application to former employees including a cooling off period. Jurisdiction or the authority of FDA to regulate remains imperative.
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