Featured Pharma Online Editorial

  1. Getting Generic Drugs Right: FDA Revises ANDA Guidance 2/14/2024

    To improve the quality of abbreviated new drug applications (ANDAs) and to ensure improved consistency, the FDA has developed a new guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval. This new guidance replaces the previous September 2020 version.

  2. Trends In FDA FY2023 Inspection-Based Warning Letters 2/13/2024

    The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

  3. Is Pre-Compression Tablet Thickness A True Critical Operating Parameter? 2/12/2024

    As recently as Nov. 2023, the topic of how pre-compression tablet thickness is viewed raised its head once again in an FDA inspection at a generic pharmaceutical company in India. This control is available on all modern tablet presses, yet instructions for its use are vague. This article shares how to use this control correctly and to be better prepared for an agency inspection.

  4. FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene 2/6/2024

    Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.

  5. Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma 2/6/2024

    In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.

  6. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

  7. A New Year's Resolution Suggestion For The FDA 1/22/2024

    Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.

  8. Need To Improve Your Change Management? Regulators Can Help With That 1/12/2024

    The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.

  9. WHO Guidance Seeks To Reduce Antimicrobials In Pharmaceutical Liquid Waste 1/11/2024
    While most nations have regulations and emission standards regarding industrial waste containing antimicrobials, there is no globally accepted framework. This new WHO guidance seeks to establish an independent, scientifically derived framework for applying targets to manage discharges from antibiotic manufacturing facilities. The public comment period ends Jan. 26, 2024.
  10. Is FDA's COVID Container Closure System Guidance Useful Post-Pandemic? 1/9/2024

    The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.