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  4. FDA’s Dosage and Administration Section of Labeling Draft Guidance - 04/19/2023
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Virtual | Virtual

Event Title
FDA’s Dosage and Administration Section of Labeling Draft Guidance
April 19 - 20, 2023

Date:
April 19 - 20, 2023
Day1:
- ET
Day2:
- ET

 

FDA’s Dosage and Administration Section of Labeling Draft Guidance

Presentations

Speaker

Dosage-Related Information in Labeling - Day 1

Dosage-Labeling-Webinar-Day-1-Slides.pdf

Q&A Discussion

Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA

Dosage Modifications and Preparation- and Administration-Related Information in Labeling - Day 2

Dosage-Labeling-Webinar-Day-2-Slides.pdf

Q&A Discussion

Eric Brodsky, M.D.

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ABOUT THESE WEBINARS

FDA will discuss the following topics in the draft guidance for industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (January 2023):

Day 1: Dosage-Related Information in Labeling

  • Dosage- and administration-related information that is particularly critical to the safe and effective use of the drug
  • Recommended dosage information including the dosage range, the starting or loading dose and dosage, titration schedule, the maximum recommended dosage, and the maximum recommended duration as well as the route(s) of administration
  • Dosage in specific populations (e.g., pediatric patients, geriatric patients, patients with renal impairment, patients with hepatic impairment)
  • Recommendations for drug discontinuation or dosage reduction when there are risks of withdrawal
  • Recommended dosage for fixed combination drug products and co-packaged products

Day 2: Dosage Modifications and Preparation- and Administration-Related Information in Labeling

  • Dosage modifications for adverse reactions or for drug interactions
  • Preparation and/or administration of the drug (e.g., parenteral products, a product stored in the refrigerator or freezer, pharmacy bulk packages, solid oral dosage forms with qualified liquids or soft foods)
  • Storage instructions for the reconstituted or diluted product.
  • Other drugs used before, during, or after drug treatment or administration

LEARNING OBJECTIVES

  • Describe
    • General principles for developing the DOSAGE AND ADMINISTRATION (D&A) section of labeling
    • Recommended dosage for fixed-combination drug products and co-packaged products
    • Preparation and administration instructions for parenteral products
    • Preparation and administration of oral dosage forms via enteral tube 
  • Discuss:
    • Recommended organization and format of the D&A section
    • Recommended dosage information and the administration instructions included with the recommended dosage
    • Administration instructions for certain dosage forms
  • Review:
    • Recommended dosage in specific populations
    • Dosage modifications due to adverse reactions and drug interactions
  • Identify the critical dosage and administration-related information
  • Incorporate other therapy used before, during, and after drug treatment/administration in the D&A section
  • Clarify storage instructions for the reconstituted or diluted product

INTENDED AUDIENCE

Pharmaceutical industry members who:

  • Work on:
    • Developing labeling for prescription drugs, including “branded” drugs (regulated under NDAs) and biological products (regulated under BLAs). Especially those that develop the DOSAGE AND ADMINISTRATION section of labeling
    • Drug communication regarding dosage, preparation, administration, or storage 
  • Are:
    • Medication error specialists
    • Nephrology specialists (e.g., nephrologists)
    • Product quality experts who develop Pharmacy Bulk Packages, drugs that are mixed with liquids or soft foods prior to administration, drugs with complicated dosage forms, or drugs that are administered via enteral tubes
  • Develop:
    • Fixed combination drug products or co-packaged products
    • Patient or healthcare practitioner Instructions for Use

FDA SPEAKERS

Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA

FDA RESOURCES

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