Biosimilar Regulatory solution center

81. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

82. Understanding And Navigating Diverse Regulatory Environments 2/21/2024

    Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.

83. New DSCSA Guidance Details Layers Of Verification System Requirements 2/15/2024

    A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

84. 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.

85. Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars 2/9/2024

    The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

86. Development And Regulation Of Veterinary Monoclonals 2/8/2024

    Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

87. Revolution In The EU Pharmaceutical Legislation Ahead 2/8/2024

    Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

88. 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.

89. 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.

90. 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.