Regulatory

  1. Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit
    3/7/2019

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  2. How To Write An Effective Validation Master Plan
    2/6/2019

    A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.

  3. An Analysis Of FDA FY2018 Drug GMP Warning Letters
    2/1/2019

    This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.

  4. Foreign Investors Trigger ‘Critical Technology’ Review for Biotech
    2/1/2019

    New, cross-border investments trigger federal scrutiny via CFIUS when emerging biotech technology is involved.

  5. Combatting Unproven Cell And Gene Therapies Through Regulation And Education
    2/1/2019

    According to the inaugural annual report from the International Society for Cell and Gene Therapy (ISCT), the number of CGTs with marketing authorization increased by 45 percent between 2015 and September 2018.

  6. 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.

  7. 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?

  8. 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.

  9. 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.

  10. 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.