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DTSTAMP:20240329T102553Z
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DTSTART:20210325T130000
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DESCRIPTION:
\nOverview
\nPrescription drug prod
uct labeling communicates the product&rsquo\;s safety and effectiveness in
formation to health care providers. Labeling summarizes the key scientific
information that health care providers need to assess if the product is a
ppropriate for use by their patient.
\nThe FDA has finalized its regu
lations on the content and format of labeling for prescription drug produc
ts\, including biological products. The final labeling regulations\, commo
nly known as the Physician Labeling Rule (PLR)\, are designed to ensure th
at health care providers have clear and concise information in prescriptio
n drug labeling\, and to make it easier for health care providers to use l
abeling to make their prescribing decisions.\n
\n
\nSession Highlights
\nThis course will provide an overview
of the guidance for labeling Biosimilar products.
\nThis guidance is
intended to help applicants develop draft labeling for proposed biosimilar
products for submission in a regulatory application.
\nTopic
1: CFR Review\n\n\n - Patient Labeling: 21 CFR 208
\n
- Revising 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 Informati
on
\n - Table of Contents
\n - Full Prescribing Information.
\n
\n \n
\nTopic 3: 2021 FDA Final Guidance for
Labeling Biosimilar Products
\no One of the first items hea
lth care professionals may notice in the Highlights section is the additio
n of a &ldquo\;Biosimilarity Statement&rdquo\; describing the biosimilar p
roduct&rsquo\;s relationship to its reference product.
\no Understand
utilizing the FDA-approved labeling for the reference product for Biosimi
lar product relevant data and information.
\no Discuss the regulation
s for a biosimilar product not requiring the same labeling as its referenc
e product\, biosimilar product labeling may differ from the reference prod
uct labeling for a variety of reasons.\n
\n
\nWho
will benefit\n\n\n - Quality Assurance
\n - Regulator
y Affairs\n
\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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