Regulatory

  1. The Impact Of CETA On The Pharmaceutical Industry
    11/8/2017

    The impact of the Comprehensive Economic and Trade Agreement (CETA) for the life sciences industry is rooted in regulatory changes surrounding IP protection and government procurement.

  2. Are These 3 Fear Factors Holding You Back From Regulatory Compliance?
    10/27/2017

    In the TV series Fear Factor, contestants had to overcome various challenges that most of us found disgusting and/or frightening in order to win a large cash prize. If they failed, their hopes were gone and the contest ended for them. The same can be true for the pharmaceutical industry in trying to achieve the “prize” of being found compliant when audited.

  3. FDA Draft Guidance On Electronic Records And Signatures: The Next Chapter
    10/26/2017

    The FDA has released a Draft Guidance titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. Certainly, the development of this draft guidance was driven by the repetitious questions the FDA has received from industry stakeholders as well as the extensive technology advancements.

  4. After The Failed Trans-Pacific Partnership: What Comes Next?
    10/10/2017

    The Obama Administration, seeking to expand international trade, negotiated the Trans-Pacific Partnership (TPP) with 11 other Pacific Rim countries. After President Trump assumed office in January, he immediately withdrew the U.S. from the multilateral agreement. The other TPP countries — now known as the TPP 11 — and other Asian countries have since been seeking a replacement low-tariff trade market.

  5. Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies
    9/27/2017

    This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.

  6. How Interested Is The FDA In Real-World Evidence?
    9/25/2017

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry.

  7. State Of Serialization: Where FDA & The Pharma Industry Currently Stand
    9/1/2017

    For the Drug Supply Chain Security Act to be effective, it requires pharma to institute electronic, interoperable systems that enable stakeholders to identify and trace drugs distributed into the U.S. 

  8. What Can Scott Gottlieb Do To Advance The FDA & Clinical Trials?
    8/31/2017

    On May 11, Scott Gottlieb, M.D., officially became the 23rd commissioner of the U.S. Food and Drug Administration (FDA). Dr. Gottlieb has previous FDA experience, having served as deputy commissioner for medical and scientific affairs, among other positions, during the George W. Bush administration.

  9. How The FDA Views Natural Language Processing
    8/9/2017

    According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.

  10. The Supreme Court’s Upcoming Review Of IPR Constitutionality — A Biopharma Perspective
    7/31/2017

    IPR provides an adversarial process for challenging patents at the U.S. Patent Office. As of earlier this year, there were over 50 IPR petitions reportedly on file challenging patents relating to the large molecule biopharma space.