LSL Web-Exclusive Content

  1. 5 Questions To Ask Your CDMO: #5 — What Is Your Employee Turnover?
    1/15/2019

    Virtually every biotech or pharmaceutical company relies on contract development and manufacturing organizations (CDMOs) for R&D and manufacturing services or to access specialized technology to bring their drug candidates to the market. Identifying and selecting CDMOs is a lengthy and difficult process, and it is critically important to select the right partner.

  2. Are You The Weak Link In Your Own Pharma/Biotech Supply Chain? How To Find Out — And Fix It
    1/14/2019

    A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.

  3. 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.

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     The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in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

  5. The Evolution Of Compassion: Janssen’s Innovative Collaboration On Behalf Of Seriously Ill Patients
    1/2/2019

    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.

  6. 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.

  7. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019
    12/26/2018

    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.

  8. 3D Printing In The Pharmaceutical Industry: Where Does It Currently Stand?
    12/21/2018

    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.

  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. Top Trends In The Biopharmaceutical Industry And Bioprocessing For 2019
    12/18/2018

    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.