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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....

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Adaptive 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...

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Tufts 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...

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Taming 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...

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Differences 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...

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How 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...

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March 2019 | New FDA 483s

In March of 2019, we added 216 483s to our database of 27,500+ FDA inspection documents.

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Data 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?

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Week 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.

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Data 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.

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Week 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.

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Data 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.

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Week 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.

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April 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...

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Week 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.

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10 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.

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Week 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.

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May 2019 | New FDA 483s

In May of 2019, we added 262 FDA 483s to our database of 27,500+ FDA inspection documents.

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Week 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.

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How 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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