LSTI Headlines

  1. 4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)
    9/19/2016

    After countless hours putting together your 510(k) submission, the last thing you  expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.

  2. What Is Continuous Manufacturing, Anyway? Agreeing On A (Proper) Definition
    8/30/2016

    In the past 10 years, continuous manufacturing (CM) has gone from theoretical discussion to manufacturing reality. However, the pharmaceutical industry has not yet explicitly defined the term “continuous manufacturing,” nor has it ensured that the term’s usage is aligned with other industries.

  3. The 5 Basic Tenets Of Data Integrity — And How Failures Occur
    7/14/2016

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

  4. Training Effectiveness – A Quality By Design Approach
    7/1/2016

    Training effectiveness seems to be a topic that is percolating, especially in GMP environments. Yet, it’s shrouded in mystery. No one is clear on what it is, how to implement it, and what the regulators are looking for when it comes to effective training.

  5. Accelovance Addresses CRA Shortage With Accelovance Academy Inaugural Graduation Class
    6/8/2016

    Accelovance, Inc. (Accelovance), a global contract research organization (CRO) focusing in vaccines, oncology, and general medicine clinical research held a graduation ceremony yesterday for Accelovance Academy's inaugural class of Clinical Research Associates (CRAs).

  6. FDA’S 3D Printing Draft Guidance Leaves Much Unresolved, Even More Unknown
    5/26/2016

    3D printing of medical devices will revolutionize and disrupt healthcare as we know it. The U.S. Food and Drug Administration (FDA) has already cleared more than 80 medical devices and one prescription drug that are produced by 3D printing techniques.

  7. Human Error: How To (Accurately) Identify & Address It Using Performance Models
    5/18/2016

    After giving a recent course on reacting to human error, one of the attendees sent me a variety of questions about how to apply the human performance models we discussed in FDA-regulated environments.

  8. Merck Changes The Paradigm On Clinical Trials
    5/11/2016

    Patient centricity remains a hot topic in the clinical space, and generated a significant amount of discussion at the CROWN Congress in Philadelphia earlier this year. Few would argue this will be a critical factor in turning around patient perceptions of the pharma industry, and hopefully solve the patient recruitment and retention issues that have long plagued the industry.

  9. Pitch Perfect Minority Patient Recruitment
    5/10/2016

    Beyond securing more critical study volunteers across the board, the hot-button issue continuing to plague Big Pharma and clinical research (the industry) is how to get more minorities to participate in clinical trials.

  10. Applying Human Performance Models In FDA-Regulated Environments
    4/15/2016

    This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.