By Elaine Whitmore
Many adjustments to the class and legislation of pharmaceuticals, biologics, and scientific units have happened because the past version of this ebook was once released in 1997 below the name Product improvement making plans for health and wellbeing Care items Regulated via the FDA. This revised variation comprises: up-to-date proof and figures; growth of matters that experience grown extra serious, reminiscent of scientific results, human components, and advertising targets; and extra new subject matters similar to the function of product improvement in threat research, recollects, and product legal responsibility. the writer additionally covers the nutrients and Drug Administration’s Modernization Act (FDAMA), besides discussions on highbrow estate, pharmacoeconomics, and technological and clinical developments. This ebook is meant as a beginning for somebody taken with product improvement of prescription drugs, biologics, or clinical units undefined. beneficial references comprise a word list, acronyms, and a listing of important assets.
record of Figures and Tables
desk of Contents
Part I. designated demanding situations in clinical Product Development 1. Healthcare within the usa
2. it isn't Your Father's FDA: The "Modernization" of clinical Product rules
three. Product legal responsibility and Product improvement
Part II. Bringing a brand new clinical Product to industry four. evaluation of the Approval procedures for medicinal drugs, Biologics, and scientific units
five. Designing-in caliber
6. Designing-out catastrophe: probability research
7. remembers, Revocations, and Withdrawals
eight. Human elements and the character of Relationships: Minimizing clinical blunders
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. elements of Product improvement making plans: The Product improvement method
thirteen. elements of Product improvement making plans: improvement Portfolio administration
14. parts of Product improvement making plans: know-how evaluate
15. elements of Product improvement making plans: expertise Forecasting
sixteen. extra for the Laundry checklist: advertising and marketing, Patents, Budgets, video games, and caliber
17. the place can we cross from the following?
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Extra info for Development of FDA-Regulated Medical Products - Prescription Drugs, Biologics, and Medical Devices
The fact that compliance with government and industry regulations standards or practice does not automatically result in a design being reasonably safe is never an excuse for lack of compliance. The failure of a medical products manufacturer to comply with FDA regulations is neither permissible, nor ethical, nor good business. So don’t skimp on product testing or on risk analysis exercises, which are discussed elsewhere in this book. Both can reveal nonobvious product defects. Diligence in those processes can help to keep your company out of court.
Specifically, the device must be regarded as substantially equivalent to a “predicate device,” usually one marketed before the 1976 Medical Device Amendments (that is, a preamendment device); the predicate device can also be a postamendment device that has already been found to be substantially equivalent to a preamendment device. The FDA will find the new device equivalent if, after reviewing the submission, the FDA is convinced that: • The device performs the same function and falls within an established type of predicate device.
One important point for those unaccustomed to or uninitiated in regulatory matters is that despite FDA efforts to streamline regulatory processes, a company does not obtain FDA clearance or approval to market a new healthcare product by simply filling out an application form. Submitting the documentation for a 510(k), PMA, NDA, or BLA is not like applying for a loan or a driver’s license. Depending upon the product, these submissions may range in length from less than 100 pages (for example, for some medical devices) to hundreds of thousands of pages (for example, for some drugs with extensive clinical data).
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