FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

FDA Regulatory Affairs:

• provides a blueprint to the FDA and drug, biologic, and medical device development
• offers current, real-time information in a simple and concise format
• contains a chapter highlighting the new drug application (NDA) process
• discusses FDA inspection processes and enforcement options
• includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA

Three all-new chapters cover:

• clinical trial exemptions
• advisory committees
• provisions for fast track

List Price: $ 200.00



Price: $ 169.83



Medical Errors and Medical Narcissism





Disclosing a harm-causing medical error can be one of the most anguishing conversations a healthcare professional can have. In addition to fears that disclosure might lead to a lawsuit, a harm-causing error can also assault the professional’s sense of competency and adequacy. Often, the necessary conversation between healthcare professional and patient or family is avoided or conducted very poorly.

Medical Errors and Medical Narcissism examines the concept of "medical narcissism" and how error disclosure to patients and families is often compromised by the health professional’s need to preserve his or her self-esteem at the cost of honoring the patient’s right to the unvarnished truth about what has happened.

This groundbreaking book explores common psychological reactions of healthcare professionals to the commission of a serious harm-causing error and the variety of obstacles that can compromise ethically sound, truthful disclosure. Insights are offered on how talented, capable persons who feel a driving need to demonstrate their competence can fall into narcissistic traps. Guidance on disclosing errors artfully and ethically is provided through a series of step-by-step recommendations along with a list of particularly helpful words and phrases.









List Price: $ 76.95



Price: $ 25.55







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