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  • Antero Pharma Consultant

Major USFDA Regulatory Updates in April 2023



  • On April 05, FDA issued draft guidance on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act”. This guidance provides recommendations to applicants on providing timely notification to the FDA about the permanent discontinuation of the manufacturing and supply of drug substances and products to prevent or mitigate drug shortages. Additionally, this guidance explains how the FDA communicates to the public about drug shortages. This guidance replaces the draft “Notifying FDA of a 34 Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C 35 Act,” issued in March 2020.

  • On April 05, FDA issued draft guidance on “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” This guidance provides recommendations to stakeholders (patients, caregivers, researchers, product developers) regarding the methods, standards, and technology used to collect and submit patient exposure data (Clinical outcome assessment) to the FDA. This information can be used for drug development and regulatory decision-making, including selecting the clinical outcome assessment to determine the clinical endpoints.

  • On April 12, FDA issued draft guidance on “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.” The purpose of this guidance is to assist applicants regarding planning, developing, addressing, and communicating results to the FDA of risk-based approaches to monitor the conduct of clinical investigations of small molecules, biologics, medical devices, and combination products. This guidance is an expansion of the FDA’s guidance “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, issued in April 2013.

  • On April 13, FDA issued draft guidance on “Over-the-Counter Monograph Order Requests: Format and Content.” This guidance assists applicants in preparing the format and content of the eCTD monograph application for the OTC products to be submitted to the FDA under section 505G of the FD&C Act. The specific data, studies, and related information are not within the scope of this guidance. However, applicants can request formal meetings to discuss these topics.

  • On April 20, FDA issued draft guidance on “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” This guidance provides information and recommendations to the sponsors involved in developing the drugs used to prevent or treat acute radiation syndrome caused by exposure to ionizing radiation from accidental or deliberate events. The general principles expressed in this guidance are based on the available guidance “Product Development Under the Animal Rule,” issued in October 2015.







Note: We acknowledge that there are other FDA updates for April, but we would like to highlight the significant updates only.


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