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FDA will discuss the following topics in the draft guidance for industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (January 2023):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

CONTINUING EDUCATION

These webinars have been approved for 1.50 contact hours each of continuing education for physicians, pharmacists, and nurses. Please see detailed announcements for Day 1 and Day 2 for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
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