By Elaine Whitmore
Many adjustments to the class and law of pharmaceuticals, biologics, and scientific units have happened because the past version of this booklet was once released in 1997 less than the identify Product improvement making plans for health and wellbeing Care items Regulated by way of the FDA. This revised version comprises: up to date evidence and figures; growth of topics that experience grown extra serious, resembling scientific results, human elements, and advertising ambitions; and extra new themes equivalent to the function of product improvement in danger research, remembers, and product legal responsibility. the writer additionally covers the nutrients and Drug Administration’s Modernization Act (FDAMA), in addition to discussions on highbrow estate, pharmacoeconomics, and technological and scientific traits. This e-book is meant as a starting place for somebody occupied with product improvement of prescribed drugs, biologics, or clinical units undefined. useful references contain a word list, acronyms, and an inventory of beneficial assets.
record of Figures and Tables
desk of Contents
Part I. particular demanding situations in scientific Product Development 1. Healthcare within the usa
2. it is not Your Father's FDA: The "Modernization" of clinical Product law
three. Product legal responsibility and Product improvement
Part II. Bringing a brand new scientific Product to industry four. evaluate of the Approval strategies for medications, Biologics, and clinical units
five. Designing-in caliber
6. Designing-out catastrophe: chance research
7. recollects, Revocations, and Withdrawals
eight. Human elements and the character of Relationships: Minimizing scientific mistakes
nine. Is it secure and Does it Work?: comparing defense and Efficacy in medical Trials
10. How a lot is the Product relatively Worth?: results examine, Pharmacoeconomics, and controlled Care
Part III. Product improvement making plans eleven. versions and Metaphors: Product improvement and the Product improvement association
12. parts of Product improvement making plans: The Product improvement procedure
thirteen. parts of Product improvement making plans: improvement Portfolio administration
14. elements of Product improvement making plans: expertise evaluate
15. parts of Product improvement making plans: know-how Forecasting
sixteen. extra for the Laundry record: advertising, Patents, Budgets, video games, and caliber
17. the place will we move from the following?
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Extra resources for Development of FDA-Regulated Medical Products - Prescription Drugs, Biologics, and Medical Devices
These fees are analogous to the PDUFA fees discussed earlier. Increased Surveillance of Medical Devices The FDA announced that it will require manufacturers of certain critical medical devices to conduct post-market surveillance on those products. The devices are those for which failure would reasonably be expected to cause severe adverse consequences. This surveillance will provide a way for the FDA (and manufacturers) to identify problems that were not identified during the course of product development.
The technological characteristics of the new device are comparable to the predicate device. • Whatever differences in characteristics that do exist between the new and predicate device will not raise any new safety and effectiveness questions. Special Controls Special controls apply to Class II medical devices. Class II devices are those for whom General Controls alone are not adequate to assure the safety and effectiveness of a device, based on the potential of risk to health posed by the device.
12 In other words, the federal law does not preempt state law with regard to certain medical device product liability. S. national class action product liability settlements. 75 billion $ 1 billion Possibly > $2 billion* * As of May 2003, company had settled 740 suits for $219 million, and had approximately 8600 additional personal injury suits pending in the United States. 13 There is no explicit federal preemption provision for pharmaceutical products, which seriously weakens any hope for protection of therapeutic products from civil suits.