FDA Inspectors Crave a Good Hot Cup of CAPA
One of my favorite all-time bands, The Kinks, have a fantastic tongue-in-cheek song called “Have a… [more]
CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management
Deciphering the FDA is a bit like trying to understand what the old USSR was up to in the days of the… [more]
FDA Provides Important Clinical Trials Guidance
In the age of electronic documents and electronic signatures, the FDA is still defining and providing… [more]
Misguided FDA Food Regulations Will Hike Costs, Not Safety
2012 will mark another year of aggressive food regulation at the FDA. On tap, salt regulations and industry-wide… [more]
Obama Executive Order on Drug Supply Misses The Point
The Obama Administration's recent Executive Order Reducing Prescription Drug Shortages states that some… [more]
Can the U.S. Maintain its Leadership Position in Medical Devices?
According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival… [more]
Everyone Agrees the FDA 510(k) Process Needs to be Fixed
Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the… [more]
Featured Posts
FDA Inspectors Crave a Good Hot Cup of CAPA
One of my favorite all-time bands, The Kinks, have a fantastic tongue-in-cheek song called “Have a Cuppa Tea” that satirizes the British belief that a good hot cup of tea will solve all of the world’s problems. I think the FDA misread “Cuppa” and instead decided that if it focused on CAPA it, too, would solve all the of the … [Read More...]
CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management
Deciphering the FDA is a bit like trying to understand what the old USSR was up to in the days of the Cold War. In those days, it was called Kremlinology, or the study of a complex, secretive organization. We need a catchphrase for those of us today who try to figure out what the FDA means when it says something, or what it means when it says … [Read More...]
FDA Provides Important Clinical Trials Guidance
In the age of electronic documents and electronic signatures, the FDA is still defining and providing guidance for 21 CFR Part 11 concepts it began in 2003. It seems we all really need to catch up. Now that FDA provides small business webinars and blogs about “the most pressing public health issues of the day”, it is refreshing to note … [Read More...]
Misguided FDA Food Regulations Will Hike Costs, Not Safety
2012 will mark another year of aggressive food regulation at the FDA. On tap, salt regulations and industry-wide regulations dictating which foods can be advertised on television. In October last year, the FDA announced in the Federal Register that it would begin accepting comments on “approaches to reducing sodium consumption.” The … [Read More...]
Obama Executive Order on Drug Supply Misses The Point
The Obama Administration's recent Executive Order Reducing Prescription Drug Shortages states that some health care providers may hoard drugs that are in short supply. I am wondering how this is possible if the drugs are not even available to hoard? In this Executive Order it specifically states that root cause analysis and solutions may be out … [Read More...]
Can the U.S. Maintain its Leadership Position in Medical Devices?
According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival countries – mainly Brazil, China and India. However, the U.S. innovation edge may face more threats from an inefficient American regulatory system, according to AdvaMed. Unveiling its "Competitiveness Agenda" at device maker Stryker in … [Read More...]
Everyone Agrees the FDA 510(k) Process Needs to be Fixed
Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the FDA’s 510(k) review process, but there’s a tension underneath it all: Industry generally thinks the FDA is way too slow and inconsistent in its 510(k) review process and threatens medical device innovation in the US, and FDA seems to agree … [Read More...]