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DTSTAMP:20240328T172612Z
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DTSTART:20210325T130000
DTEND:20210326T130000
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DESCRIPTION:Overview
\nPrescription drug product labe
ling communicates the product&rsquo\;s safety and effectiveness informatio
n to health care providers. Labeling summarizes the key scientific informa
tion that health care providers need to assess if the product is appropria
te for use by their patient.
\nThe FDA has finalized its regulations
on the content and format of labeling for prescription drug products\, inc
luding biological products. The final labeling regulations\, commonly know
n as the Physician Labeling Rule (PLR)\, are designed to ensure that healt
h care providers have clear and concise information in prescription drug l
abeling\, and to make it easier for health care providers to use labeling
to make their prescribing decisions.\n
\n
\nSessio
n Highlights
\nThis course will provide an overview of the g
uidance for labeling Biosimilar products.
\nThis guidance is intended
to help applicants develop draft labeling for proposed biosimilar product
s for submission in a regulatory application.
\nTopic 1: CFR
Review\n\n\n - Patient Labeling: 21 CFR 208
\n - Revi
sing Biosimilar Product labeling: 21 CFR 601.12
\n
\nTopic
2: Biosimilar labeling specifics\n\n\n - Labeling includes
three sections:\n
\n - Highlights of Prescribing Information
\
n - Table of Contents
\n - Full Prescribing Information.
\n
\n \n
\nTopic 3: 2021 FDA Final Guidance for Labelin
g Biosimilar Products
\no One of the first items health care
professionals may notice in the Highlights section is the addition of a &
ldquo\;Biosimilarity Statement&rdquo\; describing the biosimilar product&r
squo\;s relationship to its reference product.
\no Understand utilizi
ng the FDA-approved labeling for the reference product for Biosimilar prod
uct relevant data and information.
\no Discuss the regulations for a
biosimilar product not requiring the same labeling as its reference produc
t\, biosimilar product labeling may differ from the reference product labe
ling for a variety of reasons.\n
\n
\nWho will ben
efit\n\n\n - Quality Assurance
\n - Regulatory Affair
s
\n
\n
SUMMARY:Regulatory Guidance Overview on Labeling for Biosimilar Productions
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SUMMARY:Regulatory Guidance Overview on Labeling for Biosimilar Productions
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