Regulatory Articles

81. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

    Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

82. Trends In FDA FY2022 Inspection-Based Warning Letters 2/21/2023

    We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.

83. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

84. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

85. Longhorn's Path To A Universal Influenza Vaccine 12/2/2022

    Thanks to the long-term planning of one biopharma family and some help from the U.S. Army, a universal influenza vaccine is coming soon to a clinical trial near you.

86. Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations 10/14/2022

    This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.

87. FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner 10/6/2022

    Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

88. Attributable Data Integrity in Modern Biopharma Using ALCOA Principles 8/29/2022

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.

89. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

    The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

90. Data: The Near Future Of Regulatory Info Management In Europe 7/29/2022

    Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.