FDA Featured Articles
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FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
6/23/2014
On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
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FDA Approval Pushes Novartis Into 21st Century Vaccine Development
6/18/2014
In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.
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Human Error Is The Leading Cause Of GMP Deviations – Or Is It?
5/1/2014
Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick. Every company wrestles with human error. We know humans have error rates – we’re not perfect. But how many is too many?
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The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
3/21/2014
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization. The warning letter stated in part:
“In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this CGMP violation. You are responsible for ensuring that the test methods used by your firm are validated.” (Emphasis added)
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5 Questions To Ask Yourself Before The Inspectors Do
3/10/2014
Since the FDA began releasing its annual Summary of Inspection Observations report in 2006, the number one cited observation in FDA 483s every year has been quality control unit failures. The second most cited FDA observation, failure to thoroughly review unexplained discrepancies/meet expectations, is also the most frequently cited observation by Europe’s Medicines and Healthcare products Regulatory Agency (MHRA). In order to measure your GMP compliance, as well as the effectiveness of your processes and people, ask yourself the following five questions.
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Strong Data Is Generated By Strong People
3/7/2014
By Joanna Gallant, Joanna Gallant Training Associates
In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them.
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FDA And Industry Experts Offer Guidance For DQSA Preparation
3/3/2014
It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.
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Janet Woodcock’s Quality Agenda At CDER
2/2/2014
New mandates, new user fees, and new uncertainties occupy the FDA’s drug center in 2014.
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Supplier Audits Or Bust: Six Keys To Pharma Audit Success
1/6/2014
Supply chain integrity is necessary to a pharmaceutical company’s success. When dealing with a multitude of suppliers spanning several geographies, manufacturing issues can arise if proper protocols are not in place. Specific challenges include product purity, regulatory compliance, safety, cost containment and quality assurance.
Audit processes are an integral component of supply chain management. Conducting an effective audit empowers pharmaceutical companies and their suppliers to raise performance levels and strengthen relationships while improving patient-care quality. The mutual benefits of a successful audit include:
- Supply chain continuity and reliability;
- Cost reductions;
- Improved risk management;
- Global visibility; and,
- Enhanced customer satisfaction.
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Drug Take-Back Programs – Coming To A Municipality Near You
10/2/2013
While some believe self-funded regulatory agencies to be a good thing, others feel it allows industry to have major leverage over FDA policy decision making.