Conference | Mixed
Event Title
Regulatory Education for Industry (REdI): 2019 CDER Prescription Drug Labeling Conference – Dec. 4-5, 2019
December 4 - 5, 2019
Event Title
Regulatory Education for Industry (REdI): 2019 CDER Prescription Drug Labeling Conference – Dec. 4-5, 2019
- Date:
- December 4 - 5, 2019
- Time:
- 8:00 a.m. - 5:00 p.m. ET
- Location:
-
Event LocationAttend Online or
The Hotel at the University of Maryland
7777 Baltimore Avenue
College Park, MD 20740
United States
| Session Recordings | Speaker |
|---|---|
| Voluntary PLR Conversions and Updating Prescribing Information | Eric Brodsky Associate Director, Labeling Policy Team (LPT) Office of New Drug Policy (ONDP) Office of New Drugs (OND) | CDER |
| Indications and Usage & Drug Abuse and Dependence Sections of Labeling | Iris Masucci Special Assistant for Labeling Office of Medical Policy (OMP) | CDER |
| Adverse Reaction Information in Prescribing Information | Jeanne Herndon Clinical Advisor for Labeling LPT | ONDP | OND | CDER |
| Pediatric Information In Prescribing Information | Eric Brodsky Associate Director LPT | ONDP | OND | CDER |
| The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? |
Miriam Dinatale Team Leader Maternal Health Team (MHT) Division of Pediatric and Maternal Health (DPMH) OND | CDER Kristie Baisden Medical Officer MHT | DPMH | OND | CDER |
| Labeling Case Study: Transformation of an Indication | Ann Marie Trentacosti Medical Lead LPT | ONDP | OND | CDER |
| Panel Questions and Discussion | Eric Brodsky, Miriam Dinatale, Kristie Baisden, Ann Marie Trentacosti, and Tamara Johnson Team Leader MHT | DPMH | OND | CDER |
| Labeling Finalization: Final Check of Prescribing Information | John Gallagher Science Policy Analyst LPT | ONDP | OND | CDER |
| Improving the Accuracy of SPL Submissions “The Missing LOINC” | Farrokh Sohrabi Clinical Advisor for Labeling LPT | ONDP | OND | CDER |
| Panel Questions and Discussion | John Gallagher and Farrokh Sohrabi |
| Labeling for Biological Products | Ruby (Chi-Ann) Wu Captain, U.S. Public Health Service, Labeling Reviewer Office of Therapeutic Biologics and Biosimilars (OTBB) OND | CDER Jessica Greenbaum Regulatory Counsel OTBB | OND | CDER |
| A Recipe for Clinical Pharmacology Information in Labeling | Joseph Grillo Associate Director of Labeling and Health Communication Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) | CDER and joining for the panel: Mongthuong Tran Labeling Reviewer and Health Communication Specialist OCP | OTS | CDER |
| Instructions for Use | Morgan Walker Lieutenant Commander, United States Public Health Service Senior Patient Labeling Reviewer Division of Medical Policy Programs (DMPP) Office of Medical Policy Initiatives (OMPI) | OMP | CDER and joining for the panel: Bryon Pearsall Division Director DMPP | OMPI | OMP | CDER LaShawn Griffiths Associate Director for Patient Labeling DMPP | OMPI | OMP | CDER |
| Product Title & Initial US Approval in the Highlights Section | Debra Beitzell Clinical Advisor for Labeling LPT | ONDP | OND | CDER |
| Drug Product Nomenclature | Jibril Abdus-Samad Lieutenant Commander, United States Public Health Service Policy Lead, Compendial Operations and Standards Staff Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ) | CDER |
| Panel Questions and Discussion | Debra Beitzell and Jibril Abdus-Samad |
| Safety Considerations for Container Labels and Carton Labeling | Chi-Ming (Alice) Tu Lieutenant commander, United States Public Health Service Team Leader Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) | CDER |
| Prescribing Information and Carton/Container Labeling Consistency | Eric Brodsky Associate Director LPT | ONDP | OND | CDER |
| Panel Questions and Discussion | Chi-Ming (Alice) Tu and Eric Brodsky |
About
The goal of this interactive conference is to provide useful information on prescription drug labeling development and discuss recently published FDA labeling guidances. FDA labeling specialists will present their unique perspectives concerning approaches and challenges in developing the Prescribing Information, FDA-approved patient labeling, and carton/container labeling, and will discuss methods to improve the quality of Structured Product Labeling (SPL) submissions.
Meeting participants (in-person and online) will have an opportunity (as time allows) to share their experiences and ask questions during dedicated Q&A panels.
TOPICS COVERED
- Updating labeling
- Overview of recently published draft FDA labeling guidances:
- Indications and Usage section of labeling guidance
- Drug Abuse and Dependence section of labeling guidance
- Product Title and Initial U.S. Approval in Highlights of Prescribing Information guidance
- Adverse reaction information in labeling
- Specific population information in labeling (e.g., pediatric patients, pregnant patients, lactating patients, and females and males of reproductive potential)
- Clinical pharmacology information in labeling
- Product quality information in labeling
- Labeling for biological products
- Product nomenclature
- Improving the format and appearance of Prescribing Information
- Safety considerations for container labels and carton labeling to minimize medication errors
- Improving consistency of information in the Prescribing Information and carton/container labeling
- FDA-approved patient labeling (Instructions for Use)
- Methods to improve the quality of Structured Product Labeling submissions
INTENDED AUDIENCE
Our 2019 CDER Prescription Drug Labeling Conference is intended for industry, academia, payors, healthcare information providers, and healthcare providers who
- Review, develop, submit, or use the Prescribing Information, Instructions for Use, and/or carton/container labeling
- Create or submit Structured Product Labeling files to the FDA
- Review, develop, submit, or use the Prescribing Iinformation, Instructions for Use, and/or carton/container labeling
- Create or submit Structured Product Labeling files to the FDA
LEARNING OBJECTIVES
- Update labeling when submitting New Drug Applications, Biologics License Applications, and/or supplements.
- Include recommendations from new FDA guidances into future labeling submissions (e.g., indications; pediatric use information; abuse, misuse, addiction, tolerance, and dependence information; and the product title and Initial U.S. Approval in Highlights of Prescribing Information)
- Discuss considerations for including adverse reaction information in labeling
- Incorporate pregnancy, lactation, and females and males of reproductive potential information in labeling
- Revise clinical pharmacology information in labeling according to recently published guidances
- Develop labeling for biosimilar products
- Differentiate between different dosage form terminology in labeling
- Improve the format and appearance of Prescribing Information
- Decrease risk of medication errors by improving carton/container labeling submissions
- Ensure consistency of information in the Prescribing Information and carton/container labeling
- Demonstrate clear, concise, and well-understood Instructions for Use for products that have complicated or detailed patient-use instructions
- Analyze the quality of Structured Product Labeling file submissions
FDA RESOURCES
FDA’s PLR Requirements for Prescribing Information website provides resources for the development of human prescription drug and biological product labeling regulated under New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications: PLR Requirements for Prescribing Information.
Event Materials
| Title | File Type/Size |
|---|---|
| Labeling2019_Agenda | pdf (186.65 KB) |