[ Pharmaceutical Sciences Asia - ONLINE ]
E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974


DOI: 10.29090/psa.2024.01.23.731Pharm Sci Asia 2024; 51(1), 10-18

Regulatory framework for USFDA regulated drug product labeling update

Ganesha Munesh, Madhavi Lakshmi Ratna Bhavaraju*

- Acharya and BM Reddy College of Pharmacy, Soldevanahalli, Bengaluru, Karnataka, India

The regulatory framework for USFDA-regulated drug product labeling updates is crucial for ensuring the accuracy and comprehensiveness of prescribing information. This article provides an overview of the two formats used in prescribing information: the old format and the Physician Labeling Rule (PLR) format. It explains the sections included in the PLR format, such as indications and usage, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, and more. This article gives an overview of OTC labeling, key elements that are mandated, safety-driven label change, and regulatory process by the FDA. The article also discusses the implementation of safety-related labeling changes (SrLC) describing the process of notifying and responding to the applicant(s) and addressing the evaluation procedures. The revision of Abbreviated New Drug Application (ANDA) labeling based on the Reference Listed Drug (RLD) labeling will be discussed and information will be provided about the supporting documents for the change. Overall, this article provides valuable insights into the regulatory framework for updating drug product labeling in the United States, ensuring that healthcare professionals have accurate and up-to-date information for safe and effective medication use.


Label update, ANDA label, SrLC, PLR Format, OTC Label, RLD label, Non-PLR format, PIL

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January-March 2024

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