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