Read e-book online Combination Products: Regulatory Challenges and Successful PDF

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By Smita Gopalaswamy

ISBN-10: 1420064460

ISBN-13: 9781420064469

The sector of mixture product improvement is so new that only a few guides, together with FDA records, can be found. this article offers an summary of the method from begin to end, entire with appropriate definitions, after which indicates the way to determine a layout and improvement plan. It presents an summary of FDA and different regulatory expectancies and covers source requisites, production, pitfalls, post-launch compliance necessities, and employer audits and demanding situations. The ebook offers useful guidance on how you can enhance blend items effectively and the way to enforce those items into the industry effectively and in a well timed demeanour.

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Additional resources for Combination Products: Regulatory Challenges and Successful Product Development

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9. Adverse drug experience: Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: • An adverse event occurring in the course of the use of a drug product in a professional practice • An adverse event occurring from a drug overdose whether accidental or intentional • An adverse event occurring from drug abuse • An adverse event occurring from drug withdrawal and any failure of pharmacological action 10. Disability: A substantial disruption of a person’s ability to conduct normal life functions.

Independent testing house, laboratory, or product certifier) authorized by the relevant member state’s competent authority to perform the conformity assessment tasks specified in the Medical Devices Directive. 3. MDD (93/42/EEC): The European Union (EU) Medical Devices Directive; covers, among others, normal bandages, sports tape, scalpels, surface electrodes, infusion pumps, cardiac catheters, bone cement with antibiotics, intraocular lenses, wheelchairs, crutches, external pacemakers, and installations and apparatus in operating rooms.

These activities include: design and development, risk management, regulatory, clinical, supply chain and manufacturing, quality, and postmarket service. For combination products, the plan should clearly focus on the definition of the device and the regulatory pathway, as this one aspect alone can potentially accelerate/delay product launch. We will be discussing regulatory aspects of combination products in Chapter 4. In addition to basic project planning, Monte Carlo simulation techniques are useful in answering questions such as: How do I optimize the project schedule?

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Combination Products: Regulatory Challenges and Successful Product Development by Smita Gopalaswamy


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