February 2012 Posts

New FDA Deal on Medical Device User Fees

Mark Crawford

In early February, the FDA and representatives from the medical device industry (Advanced Medical Technology Association, Medical Device Manufacturers Association, Medical Imaging and Technology Alliance) reached an agreement on recommendations for the third reauthorization of the Medical Device User Fee and Modernization Act. (more…)

The FDA Gets Moving (A Bit) on Biosimilar Guidance

Mark Crawford

On February 9 the U.S. Food and Drug Administration (FDA) released three draft guidance documents to assist biosimilar product development in the U.S.

The FDA guidance recommends a stepwise approach toward demonstrating biosimilarity that could ease trial requirements if biosimilarity can be demonstrated in earlier steps—such as a comparison between the proposed biosimilar and reference product on structure, function, animal toxicity, human pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.  (more…)

Reviving Six Sigma

Mark Crawford

There’s been some industry discussion that Six Sigma, the longtime standard of quality implementation, isn’t what it used to be—that in fact, for a growing number of companies, it is actually more of a negative than a positive.

For example,a 2007 study by QualPro revealed that 53 of 58 large companies that use Six Sigma have trailed the S&P 500 since they implemented it.

Others maintain Six Sigma is outdated and being replaced by newer methods, such as the theory of constraints and systems thinking.

However, don’t be too quick to dump Six Sigma—it’s still the same; the difference is in the way companies use it today, especially when dealing with an increasingly fast-paced and competitive global marketplace. Companies simply aren’t taking enough time and attention to implement Six Sigma properly. (more…)