Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Ambiguity (1)
- Biotechnology (1)
- Clinical trials (1)
- Disclosure (1)
- Drug approvals (1)
-
- Drugs (1)
- Federal agencies (1)
- Food and Drug Administration (1)
- Food supply (1)
- Genetically modified foods (1)
- Information (1)
- Manufacturers (1)
- Pharmaceuticals (1)
- Predictability (1)
- Private Securities Litigation Reform Act (1)
- Public health (1)
- Regulation (1)
- Risks (1)
- Safety (1)
- Substantial equivalence (1)
Articles 1 - 2 of 2
Full-Text Articles in Law
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …
Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity
Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity
University of Michigan Journal of Law Reform
This Article describes and evaluates the existing federal regulatory regime for protecting public health from risks posed by foods derived from GM plants. Part I briefly describes the technology involved in genetically modifying plants and relates the ongoing debates over the risks and benefits of GM food plants. Part II examines in detail the regulatory regime that has evolved in the United States to regulate the safety of GM foods, focusing in particular upon the pervasive role that the substantial equivalence doctrine has played in that regime. Finally, Part III suggests a more precautionary approach toward regulating GM foods that …