Guest Columns

  1. Analyzing FDA's Final Q&A Guidance On Transition Biologics 3/12/2020

    For 10 years, the date March 23, 2020 was circled in red on the FDA calendar. On that “transition date,” certain drugs FDA approved under the drug approval statute were “deemed” to have a biologics license instead of a New Drug Application approval. How soon will biosimilars see an impact?

  2. The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study 3/11/2020

    To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology. 

  3. Shifting Site Of Care For Infused Drugs: An Opportunity For Biosimilars 3/3/2020

    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.

  4. FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers 2/28/2020

    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.
     

  5. U.S. Sites Play Surprise Role In FDA’s Drug GMP Warning Letter Report 2/21/2020

    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.

  6. FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark? 2/7/2020

    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.

  7. The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter 1/31/2020

    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.

  8. Biosimilar Litigation Review: Anticompetitive Conduct Cases & Post-Grant Patent Challenges 1/30/2020

    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.

  9. Biosimilar Litigation Review: BPCIA Federal Circuit Appeals Pending & Recently Decided 1/27/2020

    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.

  10. An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report 1/27/2020

    To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle.