Resources

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. This is because the common element […]

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 […]

(Chicago) March 7, 2010 — Though it can cost hundreds of thousands of dollars to respond to a single Form FDA 483, many pharma manufacturers aren’t taking some of the basic steps needed to avoid being cited, according to new research published by FDAzilla, one of the Web’s leading sources on the business of the […]

For some companies, manufacturing is a crapshoot. There is little basis for confidence that the right equipment, materials, components, people, and records will be at the right place and the right time to begin manufacturing. And once manufacturing starts, a crystal ball is as good as anything to divine whether the product batch will be […]

The FDA has spent much of January focused on American medical device issues. In particular, they have been reviewing the regulatory status of several classes of medical devices already on the market. The latest segment of the industry to be subjected to FDA scrutiny is the manufacturing of external defibrillators. External defibrillators have gained a […]

The ease of application development afforded by the extensive community surrounding portable devices like the Apple iPhone/iPad has led to a surge in medical device-like apps being released for smart phones and tablets. An article published by Siren Interactive quoted a MobiHealthNews study that found more than 7,000 medical apps available for the iPhone in […]

I remember when I was a freshly minted executive taking a window tour of the manufacturing facility. While listening to a staff member talk about the operation, I idly traced my fingertip on an ever-so-slight mar on the finish of the corridor wall, as I was lost in thought. Little did I know the chain […]

I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation than anything else. I have divided companies with significant […]

If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you.  Here’s our list of the top 40 31 online destinations on the FDA and some of the key industries it regulates.   We applied only one criteria to make it on this list:  free, up-to-date, […]

Of course, I understand that everyone in the organization owns “quality.” Much like safety, everyone has responsibility to follow safe practices and call attention to potentially unsafe conditions. However, there also is a Safety Department that is responsible for establishing safety policies and procedures, as well as conducting periodic safety inspections. They report the safety […]