LSL Web-Exclusive Content

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     The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in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

  2. The Evolution Of Compassion: Janssen’s Innovative Collaboration On Behalf Of Seriously Ill Patients

    In 2014, an important dialogue was initiated between big pharma and big academia. The Janssen Pharmaceuticals Companies of J&J, Office of the Chief Medical Officer and the Division of Medical Ethics at NYU School of Medicine partnered to implement an innovative model to support their most important stakeholder — patients.

  3. FDA’s New Data Integrity Guidance — Highlights & Observations

    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. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

  5. 3D Printing In The Pharmaceutical Industry: Where Does It Currently Stand?

    In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.

  6. New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know

    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.

  7. Top Trends In The Biopharmaceutical Industry And Bioprocessing For 2019

    This article presents trends and findings from a survey and study of 222 responsible individuals at biopharmaceutical manufacturers and CMOs in 22 countries, as well as over 130 direct suppliers of materials, services, and equipment to this industry.

  8. Combatting The Professional Patient Problem In Clinical Trials

    Clinical research patients are compensated for their participation in clinical trials. The compensation is based on the burden the trial imposes on the patient and is vetted through an institutional review board, so patients are not overly influenced by financial gain to enroll.

  9. Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing

    Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.

  10. The Danger Of The Insider Threat, And Why Biotech And Pharma Should Care

    There are people outside of your organization who want to do you harm. But the real threat is the one you least expect: The one that's already inside your business.