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Boston University *
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Course
CH 203
Subject
Medicine
Date
Dec 6, 2023
Type
docx
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2
Uploaded by DukeGrousePerson698
Student’s Recommended Revisions to Revise the Promotional Material(s) Cited in Letter:
To revise the promotional material cited in the FDA's letter and address the concerns, the
following recommended revisions should be made:
Complexity of Use:
The promotional materials should accurately represent the
complexity of administering DSUVIA to ensure patient safety. Remove the
oversimplified claim "TONGUE AND DONE" and include a clear depiction of the
multiple administration steps, including the need to visually confirm tablet placement in
the sublingual space.
Maximum Dosage:
Clearly state the maximum daily dosage of DSUVIA, which is "Do
not exceed 12 tablets in 24 hours," to avoid creating a misleading impression about the
safe use of the drug.
Prominence of Risk Information:
Ensure that risk information, including Boxed
Warnings, Contraindications, Warnings and Precautions, and Adverse Reactions, is
presented with equal prominence and readability as benefit claims. This means using a
consistent typography, layout, contrast, and headline style to make both risk and benefit
information easily accessible.
Limitations of Use:
Emphasize the limitations of DSUVIA, including the need for its use
in certified medically supervised healthcare settings, the prohibition of use for more than
72 hours, and the requirement for administration by healthcare providers. These
limitations should be presented clearly and conspicuously.
Addiction, Abuse, and Misuse:
Highlight the risks associated with addiction, abuse, and
misuse of opioids, even when used as recommended. Reinforce the importance of
reserving DSUVIA for patients who have not tolerated alternative treatments or have not
experienced sufficient pain relief from these treatments.
Corrective Communication:
Develop a comprehensive plan for corrective
communication to disseminate truthful, non-misleading, and complete information about
DSUVIA's risks and benefits. Ensure that this corrective communication is provided to
the audience that received the initial promotional materials.
Reference:
Center for Drug Evaluation and Research. (n.d.).
Acelrx Pharmaceuticals, Inc. - 613257 -
02/11/2021
. U.S. Food and Drug Administration.
https://cacmap.fda.gov/inspections-
compliance-enforcement-and-criminal-investigations/warning-letters/acelrx-
pharmaceuticals-inc-613257-0211202
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