Mar 12, 2008
By:
Jill Wechsler
When CDER director Steven Galson left last year, Janet Woodcock shifted back as temporary chief. And now, after a long search for a replacement, she has decided to take on the job herself.
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Mar 1, 2008
By:
Jill Wechsler
More informed submissions may lead to regulatory flexibility for postapproval changes.
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The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.
Feb 1, 2008
By:
Jill Wechsler
The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.
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FDA and industry must contend with new safety policies, pricing concerns, and pressure to innovate
Jan 1, 2008
By:
Jill Wechsler
The new year begins on a note of optimism. A major breakthrough in stem cell research promises to open the door to new biomedical research opportunities. The drawn-out Congressional debate over user-fee reauthorization and drug safety regulation is over, and most parties seem satisfied with resulting compromises. The vaccine industry is experiencing a resurgence after years in the doldrums, with important new vaccines on the market and more under development. And unlike many previous years, the US Food and Drug Administration (FDA) had a confirmed commissioner for all of 2007 and relatively stable leadership.
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Medicines targeted to select patients can justify premium prices, reduce drug safety problems, and improve care
Dec 1, 2007
By:
Jill Wechsler
The personalized medicine bandwagon is on a roll, offering a new model for calculating reimbursement of high-cost biotech therapies. Strategies for identifying patients who will respond to a certain therapy, as well as those most likely to suffer adverse events, promise to improve healthcare quality while eliminating waste and inappropriate spending. Interventions based on individual genetic characteristics may have limited sales, but support higher prices and less costly clinical research methods.
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Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development
Nov 1, 2007
By:
Jill Wechsler
Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development
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From a small laboratory to a highly specialized organization, the FDA has grown with the changing needs of the biotech field
Oct 1, 2007
By:
Jill Wechsler
Federal regulation of biologics began more than 100 years ago with the enactment of the Biologics Control Act of 1902. That act required licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and other similar products in order to prevent deaths from contaminated vaccines, as had recently occurred with the diphtheria antitoxin.
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Biotech manufacturers face higher user fees plus more testing and data disclosure to prevent unsafe drug use
Sep 1, 2007
By:
Jill Wechsler
The new legislation authorizes the use of fee revenues for drug safety oversight and assessment throughout a product's lifecycle.
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New legislation offers extended data exclusivity to innovators in exchange for a flexible approval process
Aug 1, 2007
By:
Jill Wechsler
The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.
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