Dec 20, 2006
By:
Jill Wechsler
One of the last acts of former Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration (FDA).
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Action by FDA and Congress seeks to clarify manufacturing and testing requirements for less costly "comparable" biopharmaceuticals.
Dec 1, 2006
By:
Jill Wechsler
The prospect of any cost savings has been fueling efforts to establish a pathway for follow-on biopharmaceuticals.
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Compliance officials are implementing new approaches and promoting international cooperation to make inspection processes more efficient
Nov 1, 2006
By:
Jill Wechsler
FDA is working more closely with foreign regulators to keep abreast of drug and vaccine quality issues in their regions.
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New research models plus public pressures prompt manufacturers to join partnerships to develop research treatments for neglected diseases
Sep 1, 2006
By:
Jill Wechsler
There is growing support for new partnership arrangements that seek to expand drug research by reducing the financial risk for manufacturers.
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Efforts to ensure purity and safety of biotech therapies and vaccines have required innovative thinking for more than a century
Aug 1, 2006
By:
Jill Wechsler
FDA did not gain any real teeth for regulating unsafe and ineffective products until a national health disaster in 1937 roused a public outcry.
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Scientists are exploring nano-based drug delivery and production technologies, as regulatory issues arise
Jul 1, 2006
By:
Jill Wechsler
Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.
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Team model extends from biologics to drugs as ORA leadership seeks to transform inspection system
Jun 1, 2006
By:
Jill Wechsler
Glavin is preparing a plan to modernize ORA through organizational changes . . .
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New research and policies can ensure product quality through the distribution chain
May 1, 2006
By:
Jill Wechsler
The Food and Drug Administration recently unveiled its long-awaited Critical Path Opportunities List, which maps out a number of "scientific projects" for improving the testing and production of biotech therapies. In its March report, FDA recognizes that problems in the characterization, testing, and quality management of medical products can delay clinical trials and even completely block drug development.
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A multi-layered approach is needed to authenticate biotech therapies and provide a secure distribution chain
Apr 1, 2006
By:
Jill Wechsler
RFID is currently the most advanced tracking technology, but manufacturers need to pursue a multilayered approach . . .
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