Business Partners and Exchange of Safety Data
47 Business Partners and Exchange of Safety Data Development costs for a new chemical entity from creation to marketing range from $400 million to $2 billion (depending on how one…
The United States Food and Drug Administration (FDA) and MedWatch
21 The United States Food and Drug Administration (FDA) and MedWatch The “granddaddy” of drug safety “regulatory agencies” dates back to eighteenth-century Japan, when the eighth shogun, Yoshimune Tokugawa (1716–1745),…
Risk: What Is It? Risk Management and Assessment, Risk Evaluation and Minimization Systems (REMS), and Risk Management Plans (RMPs)
30 Risk: What Is It? Risk Management and Assessment, Risk Evaluation and Minimization Systems (REMS), and Risk Management Plans (RMPs) Risk is a broad concept and applies to everything in…
Audits and Inspections
48 Audits and Inspections The U.S. Food and Drug (FDA), the European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), Health Canada, and many other…
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)
24 United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is the Competent Authority that handles medicinal products, blood products,…
The Safety Department’s Role in Clinical Research, Marketing and Sales, Labeling, Regulatory, Due Diligence, and Legal Issues
42 The Safety Department’s Role in Clinical Research, Marketing and Sales, Labeling, Regulatory, Due Diligence, and Legal Issues Clinical Research The clinical research (or medical research) department is the section…
Signals and Signaling in the Context of Risk Management
19 Signals and Signaling in the Context of Risk Management Enormous efforts are made, in terms of people, time, cost, and technology, to collect AE data in companies, governments, and…
Postmarketing Spontaneous ICSR/SAE Reporting
16 Postmarketing Spontaneous ICSR/SAE Reporting Postmarketing spontaneous reporting of Individual Case Safety Reports (ICSRs) is the mainstay of drug safety at this time. General Principles The requirements for reporting…
How an Individual Case Safety Report (ICSR) Is Handled from Start to Finish
41 How an Individual Case Safety Report (ICSR) Is Handled from Start to Finish This chapter traces an adverse event (AE) through its course in a company from start to…
Pregnancy and Lactation
35 Pregnancy and Lactation Testing pregnant animals is done as part of the usual preclinical development of new drugs, but a drug that is not teratogenic (leading to congenital malformations)…
