The FDA's Quality Revolution

Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.”

In 2009, the FDA announced its Safe Use of Drugs Initiative.  The theory being that one way to make drugs safer is to ensure that they are used as directed. The main strategy was education and the agency’s efforts were (and are) aimed at physicians, nurses, pharmacists, and patients.

Earlier this year, the agency announced not just an office, but a Super Office of Pharmaceutical Quality, further underscoring that the FDA operates not under a two-dimensional system of safety and efficacy, but a three-dimensional approach that includes quality … with a capital (indeed a “super”) Q.

Since there is no such thing as a safe substandard product, the agency is putting time, resources, and the use of the bully pulpit to go beyond cGMPs, API and excipient sourcing to develop a risk-based approach that includes data gathered from a variety of sources including manufacturing inspections, adverse event reporting, and substandard pharmaceutical events as evidenced in the agency’s bioequivalence- driven actions with bupropion in 2012, metoprolol in 2014, and methylphenidate in 2015.

So, in many respects, pharmaceutical quality is both a pre and post-licensure endeavor and, like Safe Use, a scientific and educational enterprise that requires close coordination with many stakeholders. And it won’t come easily or inexpensively. As Aristotle said that, “Quality is not an act, it is a habit.”


The relevance and importance of business development and licensing in the biopharmaceutical industry.

This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology
The relevance and importance of business development and licensing in the biopharmaceutical industry.
Go to paperABSTRACT: The importance of the busines…


The reason there is no generic Daraprim

Much has been written on the controversial price increase of Daraprim. Daraprim treats malaria and another parasitic infection, toxoplasmosis. It was acquired by Turing Pharma from Impax Laboratories and shortly after the price was raised from $13.50 a tablet to $750 a tablet. The led to a quick outcry, followed by a) a defense by Turing of their drug […]


Drug Patent Expirations for Sep 24, 2015

DrugPatentWatch provides competitive intelligence on small-molecule drugs and the 90,000 global patents covering them Click the patents below for more details, or visit DrugPatentWatch.com for more options. SOMAVERT (pegvisomant) Pharmacia And Upjohn Patent number: 6,057,292 Expiration Date: Sep 21, 2015 DIPRIVAN (propofol) Fresenius Kabi Usa Patent number: 5,908,869 Expiration Date: Sep 22, 2015 DIPRIVAN (propofol) […]


Drug Patent Expirations for Sep 17, 2015

DrugPatentWatch provides competitive intelligence on small-molecule drugs and the 90,000 global patents covering them Click the patents below for more details, or visit DrugPatentWatch.com for more options. DEPODUR (morphine sulfate) Pacira Pharms Inc Patent number: 5,807,572 Expiration Date: Sep 15, 2015 INTEGRILIN (eptifibatide) Schering Patent number: 5,807,825 Expiration Date: Sep 15, 2015 For more information […]


Latest Licensable Biotechnology Inventions

TechTransferWatch is a search engine and alert service for licenseable technologies from academic labs, foundations, and government. Click the patents below for more details, or visit TechTransferWatch.com for more options. Use of the lactosylceramide synthase isoform B1,4GalT-V as a biomarker for cancer Subroto Chatterjee Johns Hopkins University Patent number: 9,134,315 Issue Date: September 15, 2015 […]


The ability to pick biotech talent: Being a better interviewer moves ‘you’ up the ladder

Journal of Commercial Biotechnology
This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

The ability to pick biotech talent: Being a better interviewer moves ‘you’ up the ladder

Go to paper

ABSTRACT: Do you know someone who has this unique skill? That person generally is respected throughout the company for his or her ability to interview well, and to spot those few who have the ‘right stuff.’ Although there is far more to the process of selecting talent than just preliminary interviews, it is indeed interviewing skills that represent the major distinction between managers…

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For more information, see the Journal of Commercial Biotechnology website


Latest Licensable Biotechnology Inventions

TechTransferWatch is a search engine and alert service for licenseable technologies from academic labs, foundations, and government. Click the patents below for more details, or visit TechTransferWatch.com for more options. TDP-43-storing cell model Tokyo Metropolitan Institute of Medical Science Patent number: 9,128,081 Issue Date: September 08, 2015 Method and device for changing the pH of […]


Global biotechnology at SXSW

Are you attending SXSW in March? Do you want to hear more about global biotechnology? BiotechBlog frequent contributor Susan Finston and I have proposed a panel on global biotechnology: FoundingBiopharma in a Hard Place: Is India Ready? I will draw on the Scientific American global biotechnology rankings I have published over the last seven years, distilling trends and […]