21 07, 2017


By | 2017-11-06T03:18:57+00:00 July 21st, 2017|Biopharma / Pharma, Clinical, FDAzilla, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The EMA published a reflection paper on July 3, 2017, that addresses ‘the requirements for selection and justification of starting materials for the manufacture of chemical active substances.’  The intent of the reflection paper, prepared by the Quality Working Party, is to clarify expectations outlined in ICHQ11, Development and [...]

9 10, 2013

How Does the Government Shutdown Impact FDA Inspections?

By | 2017-11-06T01:19:58+00:00 October 9th, 2013|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, Clinical, FDA, FDA Inspections, FDAzilla, Form FDA 483, Medical Devices|

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 data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either [...]

28 06, 2012

Differences Between Medical Device and Pharmaceutical Clinical Trials – A Primer

By | 2017-11-06T01:19:58+00:00 June 28th, 2012|510(k), Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, Clinical, FDA, FDA Enforcement News, FDA Inspection Stories, Medical Devices|

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 clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the [...]

12 04, 2012

Taming the Monster – The Economic Benefits of Adaptive Trials

By | 2017-11-06T01:19:58+00:00 April 12th, 2012|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, Clinical, FDA Enforcement News|

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 cumbersome and expensive, particularly when applied to large populations of patients over the course of a lengthy investigation. This inescapable fact has lead many investigators to consider alternative pathways to gathering the safety and [...]

23 02, 2012

Tufts Report Reveals Increased Pharma Interest in Adaptive Trials

By | 2016-07-12T16:15:10+00:00 February 23rd, 2012|cGMP Quality Assurance and FDA 483s, Clinical, FDA Enforcement News|

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 the Study of Drug Development (CSDD) recently estimated the full price of bringing a new drug to market at over $1.3 billion. The report indicated that any areas where R&D costs [...]

17 02, 2012

Adaptive Clinical Trials Can Bring You “Beyond the Shadow of a Drought”

By | 2017-11-06T01:19:59+00:00 February 17th, 2012|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, Clinical, FDA, FDA Enforcement News|

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 in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm.  According to this insightful analysis, the underlying causes have not seemed too alarming [...]