Oversight of Clinical Investigation – a risk-based approach
FDA has recently introduced a guidance document titled—“Oversight of Clinical Investigations: A Risk Based Approach to Monitoring”. FDA has not released a similar guidance for over twenty three years....
View ArticleAdaptive Clinical Trials Can Bring You “Beyond the Shadow of a Drought”
R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset...
View ArticleTufts Report Reveals Increased Pharma Interest in Adaptive Trials
Improving the efficiency of clinical trials has become one of the most important priorities for pharmaceutical companies around the world. In its annual R&D management report, the Tufts Center for...
View ArticleTaming the Monster – The Economic Benefits of Adaptive Trials
There is no question that pharmaceutical companies large and small are feeling the financial pressures associated with deploying large clinical trials. Traditional trial designs can be overly...
View ArticleDifferences Between Medical Device and Pharmaceutical Clinical Trials – A Primer
Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need...
View ArticleHow Does the Government Shutdown Impact FDA Inspections?
The government is still shut down, though the FDA is still about half-open. The question is: which half? The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales...
View ArticleMarch 2019 | New FDA 483s
In March of 2019, we added 216 483s to our database of 27,500+ FDA inspection documents.
View ArticleData Integrity Trends in 483s and Warning Letters: Part 1
Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?
View ArticleWeek of May 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device...
Enforcement included five warning letters to either homeopathic or OTC firms, continuing the FDA’s focus in this area. Fundamental GMPs seem to be missing.
View ArticleData Integrity Trends in 483s and Warning Letters: Part 2
Part two of this series will walk through our tagging methodologies and analysis on data integrity keyword 483 citations over the last five years.
View ArticleWeek of May 19th, 2019 | FDA Sent These Warning Letters to Pharma/Device...
This week’s postings included two to drug manufacturers and three to device manufacturers. FDA cites numerous repeat observations from previous inspections.
View ArticleData Integrity Trends in 483s and Warning Letters: Part 3
Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.
View ArticleWeek of May 26th, 2019 | FDA Sent These Warning Letters to Pharma/Device...
Enforcement this week saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.
View ArticleApril 2019 | New FDA 483s
In April of 2019, we added 226 483s to our database of 27,500+ FDA inspection documents. (NOTE: Are you interested in learning more about observations with specific industry keywords? Get your FREE 483...
View ArticleWeek of June 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device...
Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.
View Article10 Ways for Small and Virtual Companies to Prepare for a GMP Inspection
Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities.
View ArticleWeek of June 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device...
This was a busy week in contrast to the past two weeks in terms of posted warning letters. Seven drug warning letters and one device warning letter were posted.
View ArticleMay 2019 | New FDA 483s
In May of 2019, we added 262 FDA 483s to our database of 27,500+ FDA inspection documents.
View ArticleWeek of June 17th, 2019 | FDA Sent These Warning Letters to Pharma/Device...
Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.
View ArticleHow Mindful Leadership Supports Data Integrity
Can mindfulness influence data integrity? Discover the insights Julie Maurhoff, a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical, gained after researching the...
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