• Shifting Site Of Care For Infused Drugs: An Opportunity For Biosimilars

    An emerging target for payers is how IV drugs are distributed to providers and where these products are administered. Site of care strategies can generate cost savings, but they may also create unintended consequences. However, just as biosimilars have disrupted the status quo of the biologics market, they may also find opportunity in impacting how care is delivered.

  • FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers

    Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.

  • U.S. Sites Play Surprise Role In FDA’s Drug GMP Warning Letter Report

    Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

  • FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?

    At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” but there's a lot more to the story.

  • The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter

    This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

  • Biosimilar Litigation Review: Anticompetitive Conduct Cases & Post-Grant Patent Challenges

    This is the fourth article in a four-part series on 2019 legal developments related to the biosimilar sector. In this final installment, we cover 2019 biosimilar litigation related to anticompetitive conduct and post-grant patent challenges at the Patent Trial and Appeal Board (PTAB), and look ahead to what biosimilar developers can anticipate in 2020.

  • Biosimilar Litigation Review: BPCIA Federal Circuit Appeals Pending & Recently Decided

    This is the third article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding BPCIA district court litigation and reviewed ongoing BPCIA district court cases. Part 2 covered BPCIA district court cases that were settled in 2019. Here in Part 3, we review BPCIA Federal Circuit appeals that are pending and those that were recently decided.


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In line with a Congressional directive, the FDA must transition products previously approved as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to biologics under the Public Health Service Act (PHS Act) by March 23, 2020. This collection of articles examines the upcoming regulatory transition in depth, sharing industry and patient perspectives on the changing regulatory requirements and market access strategies and concerns for this critical class of medicines.

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