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An Overview Of Progress In The International Regulation Of The Pharmaceutical Industry, Joan Costa-Font, Aaron Burakoff Harvard University; University Of Barcelona
An Overview Of Progress In The International Regulation Of The Pharmaceutical Industry, Joan Costa-Font, Aaron Burakoff Harvard University; University Of Barcelona
The University of New Hampshire Law Review
[Excerpt] “The pharmaceutical industry, a significant source of healthcare throughout the world, has several features that distinguish it from the rest of the health industry. In the last half-century, new technology, better technological know-how, and overall economic growth have led to widespread and rapid growth in the pharmaceutical sector. Advancements in pharmaceutical research and development have led to the production of drugs that can routinely combat afflictions that, only years ago, were untreatable or even fatal. Since 1970, the average share of Gross Domestic Product (GDP) on pharmaceutical goods has increased in most Organization for Economic Cooperation and Development (OECD) …
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 …