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, we’ve all wondered – who is this masked man? Continue reading
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. Continue reading
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. Continue reading
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. Continue reading
In honor of FDA Matters’ third anniversary, I am sharing a personal story. It reflects FDA’s history as a struggle of competing interests—where sometimes reasonable people disagree, often vehemently, while at other times it is obvious that indifference or greed are the driving forces. Continue reading
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. Continue reading