Regulatory

  1. FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health
    1/11/2019

    I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.

  2. The FDA, Device Cybersecurity, And What To Expect In 2019
    1/7/2019

     The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?

  3. FDA’s New Data Integrity Guidance — Highlights & Observations
    1/2/2019

    The FDA recently posted the final guidance Data Integrity and Compliance with Drug CGMP Questions and Answers, finalizing a draft first published in April 2016. This article provides an overview and analysis of the guidance's 18 questions, which span the broad areas of data integrity and data governance.

  4. New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know
    12/19/2018

    Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.

  5. Are Regulatory Agencies Prepared For A Rapidly Aging Population?
    12/10/2018

    Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.

  6. Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!
    12/5/2018

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  7. Understanding FDA’s Quality In 510(k) “Quik” Review Program Pilot
    11/28/2018

    On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.

  8. Data Integrity In Clinical Trials: 4 Key Concerns Of The FDA & MHRA
    11/19/2018

    For the first time ever, GCP collaborations between the FDA and Medicines and Healthcare products Regulatory Agency (MHRA) were the focus of a workshop for the drug development industry. In what is projected to be the initial installment in a series, the FDA hosted the MHRA and invited interested individuals to join the workshop “Data Integrity in Global Clinical Trials — Are We There Yet?

  9. EU Drug Safety Through FMD Serialization Readiness
    11/7/2018

    Falsified medicines are a critical challenge to the safety of patients and to the reputation of the pharmaceutical industry. Serialization is a major step toward drug safety across the EU but has brought with it a set of challenges that national authorities and companies are tackling.

  10. Why Invest In Emerging Markets Now
    10/10/2018

    Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?