REGULATORY ARTICLES

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance
    Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance

    A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.

  • Will EU Patent System Changes Speed Market Entry For Biosimilars?
    Will EU Patent System Changes Speed Market Entry For Biosimilars?

    In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The goal is to achieve a balance between extension of patent protection and patent exemptions that make it easier to bring products to market in regulated industries. The commission specifically addressed the consultation to stakeholders in the biosimilar industry, among other regulated industries. The policy questions underlying patent extensions and research exemptions could have far-reaching impact on how quickly a biosimilar sponsor can get a product to market.

  • CMS’ Decision On Coding For Biosimilars: A Deeper Look
    CMS’ Decision On Coding For Biosimilars: A Deeper Look

    The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive?

  • The Impact Of CETA On The Pharmaceutical Industry
    The Impact Of CETA On The Pharmaceutical Industry

    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.

  • Are These 3 Fear Factors Holding You Back From Regulatory Compliance?
    Are These 3 Fear Factors Holding You Back From Regulatory Compliance?

    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.

  • FDA Draft Guidance On Electronic Records And Signatures: The Next Chapter
    FDA Draft Guidance On Electronic Records And Signatures: The Next Chapter

    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.

  • After The Failed Trans-Pacific Partnership: What Comes Next?
    After The Failed Trans-Pacific Partnership: What Comes Next?

    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.

  • Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies
    Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies

    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.

  • How Interested Is The FDA In Real-World Evidence?
    How Interested Is The FDA In Real-World Evidence?

    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.

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