FDA’s Dosage and Administration Section of Labeling Draft Guidance Day 1 

In this video, FDA discusses the following topic in the draft guidance for industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. Day 1 Topic: Dosage-Related Information in Labeling.
Timestamps
00:42 - Dosage and Administration Section of Labeling: Part 1 of 2
05:55 - Principles of Developing the D&A Section
17:12 - Organization and Format
28:03 - Critical Dosage or Administration-Related Information
33:03 - Fundamental Dosage- or Administration-Related Information
37:35 - Recommended Dosage in Specific Populations
53:32 - Recommended Dosage for Fixed-Combination Drug Products and for Co-Packaged Products
01:04:03 - Q&A Discussion
Speaker:
Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA
Panelist:
Eric Brodsky, M.D.
Learn more at: www.fda.gov/drugs/news-events...
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