In the Field - Pharmaceutical Technology

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In the Field

Pharmaceutical Technology
Volume 32, Issue 1

Where is that?

  • Osaka is located at the mouth of the Yodo River on Osaka Bay, in the Kansai region of the main island of Honsh, Japan. Japan's pharmaceutical hometown, Osaka is the second largest city in Japan, after Tokyo, and the world's ninth largest metropolitan area. Pharmaceutical company Tanabe Seiyaku (now merged with Mitsubishi Pharma) was founded in the city more than 300 years ago.
  • Martinsried –Planegg is a suburb of Munich in the Bayern region of Germany. It is known as the "center of the biotech cluster" with some 100 biotech companies, and in near distance to Ludwig-Maximilian University, Munich Technical University, and the Max Planck Institutes for Biochemistry.

More Funds Needed Abroad

by Angie Drakulich


Total FDA Foreign Drug Inspections, FY 2007: 494 Source: FDA, December 2007.
The US Food and Drug Administration's 2008 President's budget requests approximately $16 million* out of an overall drug inspection budget of nearly $56 million** for inspections conducted by the Office of Regulatory Affairs (ORA) of overseas drug facilities and related import activities. Despite the need for increased inspections abroad, the budget is actually $700,000 less than what the agency spent on foreign drug inspections and import activities six years ago, in 2002. According to the Government Accountability Office, 3,000 companies are registered to import drugs into the United States. But FDA was only able to conduct 310 preapproval or good manufacturing practice (GMP) inspections at these sites in FY2007. The remainder of the 494 inspections conducted abroad was primarily for bioresearch monitoring purposes (e.g., clinical investigators). The above pie chart shows where those inspections where conducted.

*Foreign inspection budget includes laboratory analyses of imported drug products, import activities at the border, and foreign inspections. **Overall budget adds domestic inspections to the foreign inspection budget request. Neither budget figure includes funds expended by FDA's Center for Drug Evaluation and Research (CDER) in support of inspections conducted by ORA.

COMING DOWN THE PIKE...

by Michelle Hoffman


Facility Roundup
The most significant early-stage discovery to hit the journals in late 2007 (or at least the most highly publicized) were the dual announcements from two independent research groups that they had managed to turn adult human skin cells into cells with properties that are seemingly identical with human embryonic stem (hES) cells. The teams each inserted four genes (only two of which overlap) into the adult cells to make them revert to the embryonic-like state. Among other things, the achievement may allow US scientists to explore the properties of hES cells—and their potential uses in regenerative medicine—while circumventing the debate on the morality of destroying human embryos to get the cells. Of course, both teams and scientific commentators stress that it will take a while to determine how similar the so-called induced pluripotent cells are to true hES cells. For now, however, it may allow US scientists to catch up to foreign counterparts studying hES cells.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
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