FDA Consent Decree

5 07, 2011

Top 30 FDA Stories | 2Q 2011

By | 2017-11-06T01:20:00+00:00 July 5th, 2011|510(k), Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Enforcement News, Medical Devices|

The FDA is having a very busy year.  Q1 saw a slew of approvals, policy changes, high-profile stories, enforcement activities, and personnel changes.  Q2 was no different.  Here are our top 30 stories on the FDA for Q2 of 2011. The Big Stories of the Quarter The Drug Shortage:  Some people say the FDA is inadvertently at fault.  Some say [...]

1 04, 2011

Top 30 stories on the FDA for Q1 2011

By | 2017-11-06T01:20:00+00:00 April 1st, 2011|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Enforcement News, Medical Devices|

by Tony Chen The first quarter of 2011 proved to be a busy one for the FDA.  We saw a deputy commissioner resign, a chemist charged for insider trading, a couple of big consent decrees, a big cancer drug approval, a big no-news on social media guidance, and more.  Here’s our wrap-up of the key developments. […]

31 03, 2011

How to Lead Your Organization Out of a Consent Decree Crisis

By | 2016-07-12T11:39:24+00:00 March 31st, 2011|CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree|

It’s a most unfortunate tragedy that the approach taken by many when addressing underlying CGMP compliance issues is effectively based in a checklist mentality—a “To Do List.”  To be sure, solving fundamental regulatory compliance problems involves tactical work that is broken down into discrete executable steps. However, I become more convinced every day that the most significant challenges in life—regulatory, [...]

16 03, 2011

FDA Consent Decrees: How do you make compliance sustainable?

By | 2017-11-06T01:20:01+00:00 March 16th, 2011|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, quality assurance|

By the time a consent decree comes along, it’s no longer a discussion about responses to Form FDA 483s observations replete with well-turned phrases—it’s about a DIY Network renovation—a complete makeover. It’s a “gut-it” approach, as never before, which exposes the cracked foundation and termite-eaten beams weakened over time. […]

10 03, 2011

FDA Consent Decrees: the Cost of Doing Business?

By | 2017-11-06T01:20:01+00:00 March 10th, 2011|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Inspections, quality assurance|

The strategic reasons behind the acquisition in the works for Sanofi to purchase Genzyme are clear. It was a matter of fixing a sale price that reflected the true current and future value of Genzyme. For those of us in the quality assurance and regulatory compliance professions, there has been the curiosity of how the history of manufacturing and compliance [...]