Category Archives: Stories

The Most Famous QA/RA Blogger Just Revealed His Identity

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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

FDA After the Election—Part 1: Budget

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

FDA’s E-Mail Scandal: First Impressions

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

Differences Between Medical Device and Pharmaceutical Clinical Trials – A Primer

Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the most important steps along the medical device regulatory pathway to market, and to explain the disparities between it and the clinical trial process for drug approval. Continue reading

Biosimilars and the U.S. Supreme Court: FDA Program Could Be Nullified

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

Today Show Hypes Medical Device Reprocessing Safety Issues

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

FDA Progress “At Risk:” An Update on Funding and a Call to Action

FDA Matters’ State of the FDA—January 2012 identified agency funding as the greatest threat to the FDA’s future.  The agency received a very small increase in FY 12 appropriated funding, reflecting the severe budgetary pressure on all U.S. federal agencies. That pressure continues and FDA faces potential cuts in FY 13 (starting October 1, 2012). Continue reading

Biological Complexity and the Myth of the Low-Hanging Fruit

Two events persuaded FDA Matters to write another column on biological complexity and its implications for medical research, drug discovery, and personalized medicine. First was the release of a remarkable study on gene mutations in cancer tumors. It is a stellar and sobering example of how biological complexity confounds our expectations that rapid advances in science will quickly lead to cures.  Continue reading

J&J: Out from the Ashes—Not.

Johnson and Johnson gutted and retooled their Fort Washington facility to come back with a bang with the launch of a new bottle designed for its grape flavored infant liquid Tylenol to guard against accidental overdosing. But instead of accolades, complaints poured in about the protective cover pushing loose when the dosing syringe was inserted. The first new product out of the new facility was added to the long list of recalls that has knocked the once respected Tylenol brand off its pedestal. Continue reading

Quality and Safety “Just Don’t Get No Respect”

In every successful company, the glittery careers and the recognizable names belong to people who develop new products that meet consumer and patient needs. Innovation in new products (and careful husbanding of intellectual property and market share) are what brings in the revenue and determines corporate success. Continue reading

FDA Guidance on Biosimilars: The Two Minute Version

If you are in the business of developing biosimilar products—or thinking about it—then you have to read all three guidance documents published by FDA on February 9, 2012. They provide essential (but not complete) instructions for how to construct and implement a biosimilar development plan. Continue reading

FDA and Industry Relations: A Mix of Frustration and Respect

There is no one answer to the question: what is the state of FDA-industry relations? FDA Mattershears some say: FDA does what industry asks it to do, the agency is a puppet. Others say that FDA is obstinately blocking industries’ path to new, better and innovative products. Yet others say FDA is misguided at points, but well-intentioned and most often right. Continue reading

Tales from the Front: With the FDA in Costa Rica

The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica.  I had been sent there from the US to help a sister company with a pending inspection.

I had arranged a dinner the night before the start of the inspection at a (supposedly) nearby restaurant in order for the FDA inspector and his wife (did I mention he brought his wife with him?) to meet the President of the Costa Rica company. With any luck, it would help the upcoming inspection go smoothly. Continue reading

So…you’re the new QA person?

New heads of Quality Assurance come into pharmaceutical companies all the time for various reasons. If you are the new head honcho of quality, hopefully you were able to get some sense for the reasons for the vacancy during the interview process. I recognize that this is not always easy in an interview situation.

I have heard such explanations as: we’re looking for someone with more of a business perspective; we’re looking for a fresh approach;  we’re looking for a partnership with QA; we’re looking for an operations-oriented QA; or we’re looking for a more progressive QA.

Actually, these all sound very positive and a highly desirable situation for a new, enlightened head of QA looking for a challenge. But like the Rorschach test, these explanations could always be interpreted various ways, some of which would be troublesome for the newbie who understands the regulatory role of QA. Continue reading