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Tuesday, June 25 • 4:15pm - 5:30pm
#295: Prescription Drug Labeling: New Guidances from the US FDA

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-643-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide updates from the US FDA on the latest developments regarding prescription drug labeling (i.e., Prescribing Information). Topics will include overviews of recently published FDA guidances, including Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products -- Content and Format, Pediatric Information Incorporated into Labeling, Product Title and Initial US Approval in the Highlights of Prescribing Information, and Labeling for Biosimilar Products.

Learning Objectives

Discuss labeling updates from the US FDA: Describe recommendations for prescription drug labeling outlined in recently published FDA guidances; Identify labeling information that is relevant for your organization.

Chair

Barbara Chong, PharmD

Speaker

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products: Content and Format
Iris Masucci, PharmD

Labeling for Biosimilar Products
Stacey Ricci, DrSc

Pediatric Information Incorporated into Labeling; Product Title and Initial US Approval in the Highlights of Prescribing Information
Eric Brodsky, MD



Speakers
avatar for Eric Brodsky

Eric Brodsky

Associate Director, Labeling Development Team, Office of New Drugs, CDER, FDA
Dr. Brodsky [as the Associate Director of the Labeling Development Team in the Office of New Drugs at the Center for Drug Evaluation and Research at the FDA] oversees OND’s implementation of Prescribing Information (PI) regulations, guidances, and policies to help promote consistency... Read More →
BC

Barbara Chong

Special Assistant for Labeling, Office of Medical Policy, CDER, FDA
Dr. Chong, Special Assistant for Labeling, joined the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER/FDA) in 2016. Her current position is primarily focused on policy and guidance development for prescription drug labeling. She works with various... Read More →
IM

Iris Masucci

Special Assistant for Labeling, Office of Medical Policy, CDER, FDA
Dr. Masucci joined FDA in 1998 and has been focusing on professional labeling and related policy since 2002. In CDER’s Office of Medical Policy, she serves as the Office lead on professional labeling policies. She leads Office efforts on the development and implementation of labeling... Read More →
SR

Stacey Ricci

Director, Scientific Review Staff, Therapeutic Biologics and Biosimilars, Office, FDA
Dr. Ricci has worked in CDER/FDA for over 11 years and is currently the Director of Scientific Review in the Office of Therapeutic Biologics and Biosimilars OTBB. OTBB works collaboratively with CDER Offices and Review divisions responsible for providing scientific and regulatory... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session