January 1, 2003
By: Jill Weschler
Congressional efforts to establish a Medicare pharmacy benefit will affect R&D, and a new FDA commissioner promises change.
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November 1, 2002
By:Jill Weschler
The agency is shifting regulation of biotech therapies to its drug center, a streamlining initiative to be implemented by a new FDA commissioner.
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October 1, 2002
By:Jill Weschler
Federal agencies seek to enhance IRB operations as new policies further expand board responsibilities.
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September 1, 2002
By:Jill Weschler
Although a Medicare drug benefit appears unattainable this year, Congress is considering other measures to reduce the cost of medicines.
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August 1, 2002
By:Jill Weschler
PDUFA III boosts manufacturer fees to expand postapproval surveillance and support new FDA review initiatives.
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July 1, 2002
By:Jill Weschler
Sponsors are underwriting more studies of children, but controversy continues over the need for FDA’s pediatric rule and the impact of extended exclusivity on generics.
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June 1, 2002
By:Jill Weschler
Rules to ensure confidentiality of individual health information threaten to make clinical trials more complex and costly.
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May 1, 2002
By: Jill Weschler
Federal prosecutors target sponsors and clinical investigators who misuse federal funds or violate research requirements while FDA proposes new policies and Congress eyes reforms.
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April 1, 2002
By:Jill Weschler
Human research protection takes a back seat, as the White House boosts funding for NIH and FDA—along with FDA user fees.
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