Implementing a Risk-Based Supplier Management Program
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
Quality & Compliance
How to Write an Effective Quality Investigation Report
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Should Data Integrity Detection be a Part of Routine cGMP Training Programs?
The FDA’s focus on data integrity in recent years has proven that it remains an industry issue. The focus has resulted in significantly increased issuance rates of 483 observations, warning letters,...
FDA’s Most Frequent 483 Observations for 2016: A Reflection of Industry’s Compliance
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
Quality & Compliance
Understanding the 21st Century Cures Act: Part II
The 21st Century Cures Act, (Passed December 13, 2016), represents three years of cooperation between Congress, the FDA, and industry to modernize the current legal framework within which the FDA...
Understanding the 21st Century Cures Act: Part I
The recent passage of the 21st Century Cures Act (passed December 13, 2016) marks a significant milestone for medical device and drug development. I recently attended a meeting held by the Food and...
The Investigation Best Practices to Avoid FDA 483 Observations
For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list....
Problem Solving: What’s the Best Approach?
Those of you in the pharmaceutical, biotech and medical device industries who encounter process and product problems on a regular basis, you likely grimace when one lands in your lap. There is a...
Quality & Compliance
Quick Guide: cGMP for Phase 1 Investigational Drugs
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Quality & Compliance
Value Found in FDA Warning Letter Reviews
Starting with the issuance of a 483, the stepwise FDA enforcement process can be illustrated as follows: Given the seriousness of a Seizure and Injunction scenario, not to mention potential jail time...
FDA Inspection? Rely on Your Vendors
If you’ve spent a reasonable amount of time in an FDA-regulated industry, you’ve most likely been part of an FDA inspection. Should you be more fortunate, you have participated directly with the...
Regulatory Sciences
FDA Issues Final Guidance on Providing Regulatory Submission in Electronic Format – The eCTD Mandate is Coming
On May 5, 2015, the Food and Drug Administration (FDA) released the final guidance on Providing Regulatory Submissions in electronic format. The guidance implements the electronic submission...
Is social media the next monitoring emphasis for the OIG?
In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to...
The Difference Between Quality and Compliance, Part II
In a blog earlier this month, I mentioned that there are recent initiatives underfoot that FDA hopes will create FDA-industry partnerships, increase transparency, utilize data more effectively, and...
The Difference Between Quality and Compliance
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their...