Principles and Practice of Pharmaceutical Medicine

provide the necessary clarification and may repre- sent corrective action. 37.3 Phase IV studies Clinical trials conducted by Me ...

analyze and report the results of clinical trials, and Site Management Organizations (SMOs), which in large part participate in ...

provide the greatest precision in diagnosis. Typi- cally if an adjudication committee is established to evaluate safety outcomes ...

Events Reporting System (AERS) of the FDA which also continuously assesses the safety of marketed drugs. This is often supplemen ...

relationships with commercial entities for full transparency. 37.6 Access to ongoing clinical trial information Increasing scrut ...

or is performed to understand the relative efficacy and safety of drugs compared to other newly available marketed medicines of ...

...

38 Drug Labeling Anthony W. Fox 38.1 Introduction The purpose of the drug label is stated succinctly in the Japanese guidelines: ...

labeling elsewhere in the world, this regulation emphasizes drug tolerability, consistent with the approach taken with much of r ...

often include not only the reviewing Division Director but also his or her superior, the Office or Center Director. The relevant ...

ingredients have been used in manufacture; (c) approved ingredients have failed some quality control that is specified in the ND ...

reader is referred. Consistency between countries is likely to increase now that drug licensing has been centralized at the Euro ...

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39 Drug Surveillance Howard J. DreskinandWin M. Castle The primary duty of a drug monitoring system is less to demonstrate dange ...

changes over time thereafter. In order to ensure continued patient protection, it is therefore neces- sary to monitor the safety ...

was also proposed. This group had no official authority, but it was hoped that the members would influence their respective gove ...

greater risk than others. If specially planned studies can help, then the protocols should be outlined. The final selection shou ...

Step 3: Comments are collected and incorpo- rated and drafts referred to the ICH steering committee. Step 4: Final draft is di ...

in a particular patient. Occasionally, a case report, even from a patient, will describe fully his/her adverse event, including ...

39.6 Labeling Product labeling describes currently known rele- vant information about a drug and is intended to aid in evaluatin ...