U.S. FDA Regulations

U.S. FDA Regulations for Clinical Trials and Drug Approvals: A Complete Guide

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The FDA’s regulatory authority covers drugs, biologics, medical devices, and more, spanning from preclinical testing through post-marketing surveillance. By establishing clear guidelines and review processes, the FDA protects public health while fostering innovation. Complying with FDA regulations not only facilitates market access in the U.S. but also enhances global credibility for sponsors.
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Regulatory Guidelines, U.S. FDA Regulations

FDA Guidance on Quality Metrics Program: Enhancing Pharmaceutical Compliance

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The FDA first introduced the concept of quality metrics in 2013 as a tool to monitor product and process quality and promote innovation. Following industry feedback and pilot studies, the agency released a revised draft guidance titled “Submission of Quality Metrics Data” in 2016 and further clarified expectations in subsequent updates.
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Regulatory Guidelines, U.S. FDA Regulations

FDA Drug Master File (DMF) Submission Guidelines for Regulatory Compliance

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A DMF is a voluntary submission to the FDA containing detailed, confidential information about the manufacture and control of a drug component. While not required by law or regulation, a DMF is a critical resource during the evaluation of Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or other regulatory submissions when a third party holds proprietary data.
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Regulatory Guidelines, U.S. FDA Regulations

FDA Clinical Hold Criteria and Procedures: A Detailed Guide for Regulatory Compliance

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A clinical hold is a regulatory mechanism used by the FDA to ensure the safety of human subjects and the integrity of clinical trials. It can be applied during IND review or at any point during the trial lifecycle. The hold may affect all or specific parts of the study and remains in effect until lifted by the FDA.
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Regulatory Guidelines, U.S. FDA Regulations

Understanding the FDA Fast Track Designation: Accelerating Drug Development for Serious Conditions

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Fast Track is an official FDA program that expedites the development and review of drugs and biologics. It is designed for therapies that treat serious conditions and demonstrate the potential to address unmet medical needs. Sponsors may request Fast Track designation at any time during the drug development process, including before or after IND submission.
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Regulatory Guidelines, U.S. FDA Regulations

Breakthrough Therapy Designation: Understanding the FDA Process for Expedited Drug Approval

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Breakthrough Therapy Designation is a regulatory status granted to drugs or biologics intended to treat serious or life-threatening conditions and that demonstrate preliminary clinical evidence indicating substantial improvement over existing therapies on clinically significant endpoints. The designation is designed to expedite the development and review of such therapies through enhanced collaboration with the FDA.
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Regulatory Guidelines, U.S. FDA Regulations

Real-Time Oncology Review (RTOR) by FDA: Fast-Tracking Cancer Drug Approvals

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The Real-Time Oncology Review (RTOR) program, launched by the FDA’s Oncology Center of Excellence (OCE) in 2018, allows the FDA to begin reviewing portions of a drug’s application (typically efficacy and safety data) before the entire New Drug Application (NDA) or Biologics License Application (BLA) is formally submitted. This rolling data submission model helps shorten the overall time to approval.
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Regulatory Guidelines, U.S. FDA Regulations