FDA Inspection Stories

24 08, 2013

The Most Famous QA/RA Blogger Just Revealed His Identity

By | 2016-07-12T12:45:12+00:00 August 24th, 2013|cGMP Quality Assurance and FDA 483s, FDA, FDA Inspection Stories, FDA Inspections, Form FDA 483, quality assurance|

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world. For years, we’ve been following The QA Pharm Blog. Writen with an equal dose of deep industry expertise, refreshing transparency/voice, and wit, [...]

1 11, 2012

FDA After the Election—Part 1: Budget

By | 2016-05-19T06:55:01+00:00 November 1st, 2012|cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Inspection Stories|

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. FDA Matters believes this is probably good—any intelligent  discussion of FDA’s future requires a long-term perspective and a mastery of detail and nuance—both of which are in short supply during “sound bite”-oriented politicking.   […]

31 07, 2012

FDA’s E-Mail Scandal: First Impressions

By | 2016-07-12T16:11:44+00:00 July 31st, 2012|cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Inspection Stories|

According to the New York Times, FDA collected more than 75,000 employee e-mails in an effort to identify leaks of confidential trade secret information. At some point, a narrow, possibly legitimate inquiry into a handful of scientists at the Center for Devices and Radiological Health (CDRH) turned into a massive e-mail surveillance of selected individuals and their contacts. […]

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 [...]

31 05, 2012

Biosimilars and the U.S. Supreme Court: FDA Program Could Be Nullified

By | 2017-11-06T01:19:58+00:00 May 31st, 2012|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Inspection Stories|

The U.S. Supreme Court will rule on the constitutionality of the Affordable Care Act (ACA) (also known as ObamaCare) no later than early July. One of the possible results is nullification of the entire Act, although FDA Matters thinks this is the least likely outcome. […]

10 04, 2012

Today Show Hypes Medical Device Reprocessing Safety Issues

By | 2016-07-12T16:10:05+00:00 April 10th, 2012|cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Inspection Stories, Medical Devices|

A recent segment on the Today show highlighted public concerns regarding hospital acquired infections – specifically, those that can be contracted from medical devices and surgical instruments. The report presented the case that even if proper sterilization processes are followed, there remains a strong chance that surgical equipment will be contaminated with blood, tissue, and fluids from previous patients. [...]

29 03, 2012

FDA Progress “At Risk:” An Update on Funding and a Call to Action

By | 2016-05-19T06:55:02+00:00 March 29th, 2012|cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Inspection Stories|

FDA Matters’ State of the FDA—January 2012 identified agency funding as the greatest threat to the FDA’s future.  The agency received a very small increase in FY 12 appropriated funding, reflecting the severe budgetary pressure on all U.S. federal agencies. That pressure continues and FDA faces potential cuts in FY 13 (starting October 1, 2012). […]

13 03, 2012

Biological Complexity and the Myth of the Low-Hanging Fruit

By | 2017-11-06T01:19:58+00:00 March 13th, 2012|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement News, FDA Inspection Stories|

Two events persuaded FDA Matters to write another column on biological complexity and its implications for medical research, drug discovery, and personalized medicine. First was the release of a remarkable study on gene mutations in cancer tumors. It is a stellar and sobering example of how biological complexity confounds our expectations that rapid advances in science will quickly lead to cures.  [...]