FDA releases guidance on pharmaceutical supply chain security

[Corona Borealis/Adobe Stock]

The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S.

So far this year, the agency has released more than a dozen guidance documents related to the development of new drugs, the use of pharmacogenomic data in drug submissions, quality considerations for cannabis-derived compounds and clinical trials for drug and biologics.

Here, we summarize the guidance on suspicious and illegitimate products, clarifying the interpretation of terms such as counterfeit, diverted, stolen, fraudulent transaction and unfit for distribution, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee). Read more

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Pharmaceutical industry trends: 2023 outlook

[Gene editing image courtesy: Illustration by Jill George using images from the National Human Genome Research Institute & the National Institute of Allergy and Infectious Diseases]

If your only tool is a hammer, everything looks like a nail. Such was the state of the pharmaceutical industry a decade ago. Gone are the days of pharmaceutical companies predominantly specializing in single modalities such as traditional vaccines, monoclonal antibodies, plasma-derived therapies or small molecules. Today’s Big Pharma, fueled by the acquisition of countless startup companies, are ensuring their toolboxes are flush with the trusty tools of the past decades. In addition, Big Pharma companies are leveraging the power of new tools in the form of advanced therapeutic modalities. Consequently, the pipelines of leading companies in the pharmaceutical industry are increasingly comprised of complex new modalities such as cell the…
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Simplifying safety reporting as part of clinical trial investigator retention 

Photo by Laura James from Pexels

The pharmaceutical industry is like many others today in that there is a high turnover rate. The surge in new clinical trials starting and post-pandemic changes in hiring amplify these concerns for clinical investigators. For example, a 2017 study using the FDA’s Bioresearch Monitoring Information system classified 54.2% of principal investigators as “one-and-done,” meaning they had only ever worked on one clinical trial and were likely not interested in participating in another. That study surveyed 201 principal investigators (PIs).

The 2017 survey also identified several factors that affect PIs’ decisions to conduct only a single FDA-regulated drug trial. Some 28.9% of the PIs decided, for personal reasons, not to conduct another trial. A total of 44.4% showed interest in participating in another trial but indicated that no opportunities were available.

The same stud…

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ATA Freight expands in India to serve growing pharma industry

The international logistics company ATA Freight is opening a new facility in Hyderabad due to growing demand from India’s quickly-growing pharmaceutical industry.

The Hyderabad facility will primarily cater to the pharmaceutical industry.

“ATA Freight already has a strong footprint in India’s pharmaceutical industry, serving many of the area’s leading pharma manufacturers,” said ATA freight chief operating officer Matt Goker. “We are also responding to the growing need from pharma companies in the Telangana region [in south-central India].”

The Telangana region is home to a high concentration of pharma companies.

India is also home to Serum Institute of India, which is the world’s largest manufacturer of vaccines.

India ranks third in the world in terms of pharmaceutical product volume.

ATA Freight has more than 30 facilities in total. Outside of India, it has sites in the U.S., Russia, Turkey, China and Mexico.

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