This document includes a great deal of technical medical detail intended to inform health care professionals who might prescribe or dispense a medicine. The PI of any approved medicine is publicly available and anybody may obtain it (from the manufacturer or from FDA, for example), but a PI is written for a professional audience. Whatever your level of scientific and/or mathematical
training, reading the PI cannot substitute for a discussion with a health care professional regarding the risks and benefits and appropriateness of a medicine in your individual circumstances.
Manufacturers typically make the PIs of their medicines available on the Web, and must include the PI as a printed “package insert” with any medicine that is sold in a box or other type of package. Note that a package insert may also include other material in addition to the PI (although you may see the
terms “package insert” and “prescribing information” referred to interchangeably in general discussion).
Given the large amount of information to be provided, newer medicines must now have a two-part PI to make it easier to find and review the information. The first part, titled Highlights of the Prescribing Information, usually takes up less than one page, but may be longer, depending on the complexity and extent of the relevant information. This section excludes much of the technical detail,
charts/graphs, and less broadly applicable information about the medicine. The second part is the full PI, with specifically labeled and numbered sections.
Although PIs for the older products cover the same types of information as for new products, some of the sections are arranged and labeled a bit differently. For instance, in PIs of older medicines, the topics Medicine Interactions, Use in Special Populations, and Patient Counseling Information are subsections of a separate Precautions section. In PIs of newer medicines, each of these three topics is presented as a separate section, and Precautions is part of a combined Warnings and Precautions section, rather than being its own section.
Some of the more important sections of the PI relating to the safe and effective use of a medicine are:
a)Indications
b)Contraindications
c)Warnings
d)Boxed Warning
e)Precautions
f)Information for patients/patient counseling information
g)Medication Guide
Tuesday, September 28, 2010
Product label
The product label is developed during the formal process of review and approval by regulatory agencies of any medicine or medical product. There are specific regulations concerning what must be included in a medicine label regarding its content, and how it works, as well as its proper administration and handling, its side effects, and its proven effectiveness and safety. The content and
presentation of any medicine’s specific labeling—originally drafted and submitted by the manufacturer—are reviewed and approved by regulatory agencies, which may require changes or additions to the label before approving the use of the medicine.
In the U.S., the complete label of a prescription medicine is made up of several documents that are approved and required by FDA—some professionally oriented and some intended for patients and consumers. The first and most comprehensive of these documents is always the professional Prescribing Information. Others may include Patient Counseling Information and a patient-oriented Medication Guide.
presentation of any medicine’s specific labeling—originally drafted and submitted by the manufacturer—are reviewed and approved by regulatory agencies, which may require changes or additions to the label before approving the use of the medicine.
In the U.S., the complete label of a prescription medicine is made up of several documents that are approved and required by FDA—some professionally oriented and some intended for patients and consumers. The first and most comprehensive of these documents is always the professional Prescribing Information. Others may include Patient Counseling Information and a patient-oriented Medication Guide.
Development Safety Update Report( DSUR)
The main focus of the DSUR is data from interventional clinical trials (referred to in this document as “clinical trials”) of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.It presents an annual review and evaluation of pertinent safety information collected during the reporting period to:
1)summarise the current understanding and management of identified and potential risks;
2)describe new safety issues that could have an impact on the protection of clinical trial subjects;
3)examine whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the product’s safety; and
4)provide an update on the status of the clinical investigation/development programme. This guideline defines the content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.
DSUR cannot be considered as:
a)An evaluation of the benefit-risk relationship for the product
b)An interim integrated safety summary (ISS) as submitted for marketing applications
c)A repository or discussion of individual adverse experience cases, unless by exception
d)A signal detection tool
e)An “expert report”
Reference: E2F
1)summarise the current understanding and management of identified and potential risks;
2)describe new safety issues that could have an impact on the protection of clinical trial subjects;
3)examine whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the product’s safety; and
4)provide an update on the status of the clinical investigation/development programme. This guideline defines the content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.
DSUR cannot be considered as:
a)An evaluation of the benefit-risk relationship for the product
b)An interim integrated safety summary (ISS) as submitted for marketing applications
c)A repository or discussion of individual adverse experience cases, unless by exception
d)A signal detection tool
e)An “expert report”
Reference: E2F
Differences between IND Annual Report and Annual Safety Report
IND ANNUAL REPORT :
purpose- progress report
Timing- IND anniversary date
Frequency- annual
Recipients- FDA
Content- study data and summary information
Feedback by may be requested regulators: may be requested
Short term end of study report safety report within trials end of study report safety report within trials for all trials within 90 days 1 year of end
Adverse events included: all serious ± associated± expected
Format and Summary: Content, Tabular summary of most frequent and most serious AEs by body system. Summary of all IND expedited reports for the period. Lists of deaths (w/ cause) and dropouts. List of completed non-clinical studies and result summary.
Annual Safety Report:
Purpose-benefit-risk assessment
Timing- Date of 1st authorization of a clinical trial of IMP by authority in member state
Frequency-annual, or on request
Recipients- EMEA, Member States, Ethics Committees
Content- benefit-risk assessment;
Content- supporting tables
Feedback by may be requested regulators:not mentioned
Short term end of study report safety report within trials: safety report within trials for all trials within 90 days
Adverse events included SUSARs; serious,associated; ± expected
Format and Summary Content: Concise global analysis; benefit-risk evaluation; implications for trial subjects; proposed measures to minimize risk; rationale for updates of study documents and procedures; supporting results of non-clinical studies; other considerations
purpose- progress report
Timing- IND anniversary date
Frequency- annual
Recipients- FDA
Content- study data and summary information
Feedback by may be requested regulators: may be requested
Short term end of study report safety report within trials end of study report safety report within trials for all trials within 90 days 1 year of end
Adverse events included: all serious ± associated± expected
Format and Summary: Content, Tabular summary of most frequent and most serious AEs by body system. Summary of all IND expedited reports for the period. Lists of deaths (w/ cause) and dropouts. List of completed non-clinical studies and result summary.
Annual Safety Report:
Purpose-benefit-risk assessment
Timing- Date of 1st authorization of a clinical trial of IMP by authority in member state
Frequency-annual, or on request
Recipients- EMEA, Member States, Ethics Committees
Content- benefit-risk assessment;
Content- supporting tables
Feedback by may be requested regulators:not mentioned
Short term end of study report safety report within trials: safety report within trials for all trials within 90 days
Adverse events included SUSARs; serious,associated; ± expected
Format and Summary Content: Concise global analysis; benefit-risk evaluation; implications for trial subjects; proposed measures to minimize risk; rationale for updates of study documents and procedures; supporting results of non-clinical studies; other considerations
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