Essentials of Healthcare Product Labeling
39
Select guidances pertaining to the content
and format of labeling for human prescription
drug and biological products33,34 include:
• Implementing the PLR Content and
Format Requirements31
• Indications and Usage Section (Draft
Guidance)35
• Dosage and Administration Section36
• Warnings and Precautions,
Contraindications, and Boxed Warning
Sections37
• Adverse Reactions Section38
• Clinical Pharmacology Section39
• Clinical Studies Section40
• Patient Counseling Section41
• Pregnancy, Lactation, and Reproductive
Potential (Draft Guidance)42,43
• Pediatric Use Subsection44
• Geriatric Use Subsection45
• Immunogenicity Information (Draft
Guidance)46
The FDA’s website is the essential resource for
labeling references material, including current
guidelines and other information about the
PLR. (See especially “Prescribing Information
Resources” tab.)47
Highlights31
Generally, healthcare professionals saw the
introduction of a Highlights section as likely to
be helpful in navigating the lengthy and complex
product labeling and recognizing the most criti-
cal product information. Manufacturers, however,
expressed concerns about excluding important
information, including context, to comply with
the succinct format of the Highlights element.
They felt it could diminish the communication of
important information and be misleading, as well
as create a basis for liability claims. Nevertheless,
the FDA proceeded to require Highlights in
the PLR format as being consistent with good
risk communication practice and cognitive
principles.16
The purpose of Highlights is to provide
healthcare professionals immediate access
to the most critical information in a concise
summary and guide them to the details in the
corresponding sections of the FPI. Highlights
text is based on the FPI but should not be a
verbatim repetition. Instead, it should consist of
succinct statements describing the most relevant
information in the FPI’s first eight sections with
recommendations for any necessary prescriber
action. Each section of Highlights is followed by
parenthetical references to the corresponding FPI
section. Highlights are limited to one-half page
however, it is possible to obtain a waiver to per-
mit a longer Highlights (e.g., for products with
numerous indications or extensive warnings). The
FDA requires a two-column format with ample
white space to enhance communication.16
Once the text of each FPI section is estab-
lished, the labeling development team can begin
extracting the critical information for the corre-
sponding section of Highlights. The time needed
to create the concise, bulleted Highlights text
should not be underestimated, given the diffi-
culty of extracting each labeling section’s essence
using precise, succinct wording. Internal discus-
sions about Highlights’ content can be lengthy,
iterative, and passionate.
“Recent Major Changes” appears under
Highlights and identifies any substantial revi-
sions only in the following sections during the
preceding 12 months. This section includes
the major headings for the revised sections, a
parenthetical reference to the corresponding FPI
section, and the month and year of the revision:
• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions
These changes are indicated in the FPI by a
vertical line in the left margin next to the revised
text. The information and corresponding vertical
line in this section should be removed after one
year (a small but significant task in maintaining
up-to-date labeling).
Full Prescribing Information – Contents
The table of contents is numbered by FPI section
heading. The table of contents does not include
sections omitted from the FPI. In that case, the
39
Select guidances pertaining to the content
and format of labeling for human prescription
drug and biological products33,34 include:
• Implementing the PLR Content and
Format Requirements31
• Indications and Usage Section (Draft
Guidance)35
• Dosage and Administration Section36
• Warnings and Precautions,
Contraindications, and Boxed Warning
Sections37
• Adverse Reactions Section38
• Clinical Pharmacology Section39
• Clinical Studies Section40
• Patient Counseling Section41
• Pregnancy, Lactation, and Reproductive
Potential (Draft Guidance)42,43
• Pediatric Use Subsection44
• Geriatric Use Subsection45
• Immunogenicity Information (Draft
Guidance)46
The FDA’s website is the essential resource for
labeling references material, including current
guidelines and other information about the
PLR. (See especially “Prescribing Information
Resources” tab.)47
Highlights31
Generally, healthcare professionals saw the
introduction of a Highlights section as likely to
be helpful in navigating the lengthy and complex
product labeling and recognizing the most criti-
cal product information. Manufacturers, however,
expressed concerns about excluding important
information, including context, to comply with
the succinct format of the Highlights element.
They felt it could diminish the communication of
important information and be misleading, as well
as create a basis for liability claims. Nevertheless,
the FDA proceeded to require Highlights in
the PLR format as being consistent with good
risk communication practice and cognitive
principles.16
The purpose of Highlights is to provide
healthcare professionals immediate access
to the most critical information in a concise
summary and guide them to the details in the
corresponding sections of the FPI. Highlights
text is based on the FPI but should not be a
verbatim repetition. Instead, it should consist of
succinct statements describing the most relevant
information in the FPI’s first eight sections with
recommendations for any necessary prescriber
action. Each section of Highlights is followed by
parenthetical references to the corresponding FPI
section. Highlights are limited to one-half page
however, it is possible to obtain a waiver to per-
mit a longer Highlights (e.g., for products with
numerous indications or extensive warnings). The
FDA requires a two-column format with ample
white space to enhance communication.16
Once the text of each FPI section is estab-
lished, the labeling development team can begin
extracting the critical information for the corre-
sponding section of Highlights. The time needed
to create the concise, bulleted Highlights text
should not be underestimated, given the diffi-
culty of extracting each labeling section’s essence
using precise, succinct wording. Internal discus-
sions about Highlights’ content can be lengthy,
iterative, and passionate.
“Recent Major Changes” appears under
Highlights and identifies any substantial revi-
sions only in the following sections during the
preceding 12 months. This section includes
the major headings for the revised sections, a
parenthetical reference to the corresponding FPI
section, and the month and year of the revision:
• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Contraindications
• Warnings and Precautions
These changes are indicated in the FPI by a
vertical line in the left margin next to the revised
text. The information and corresponding vertical
line in this section should be removed after one
year (a small but significant task in maintaining
up-to-date labeling).
Full Prescribing Information – Contents
The table of contents is numbered by FPI section
heading. The table of contents does not include
sections omitted from the FPI. In that case, the