View from Washington

Aug 01, 2002
Applied Clinical Trials
PDUFA III boosts manufacturer fees to expand postapproval surveillance and support new FDA review initiatives.
Jul 01, 2002
Applied Clinical Trials
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.
Jun 01, 2002
Applied Clinical Trials
Rules to ensure confidentiality of individual health information threaten to make clinical trials more complex and costly.
May 01, 2002
Applied Clinical Trials
Federal prosecutors target sponsors and clinical investigators who misuse federal funds or violate research requirements while FDA proposes new policies and Congress eyes reforms.
Apr 01, 2002
Applied Clinical Trials
Human research protection takes a back seat, as the White House boosts funding for NIH and FDA?along with FDA user fees.
Mar 01, 2002
Applied Clinical Trials
FDA is revising policies to ensure that clinical studies generate sufficient data to ensure the safe use of new medical products.
Feb 01, 2002
Applied Clinical Trials
A proposed policy on Data Monitoring Committee functions and operations raises important issues about the conduct of studies and the evaluation of data.
Jan 01, 2002
Applied Clinical Trials
Efforts to ensure the safety and integrity of clinical trials will generate new standards and expand oversight initiatives.
Nov 01, 2001
Applied Clinical Trials
Efforts to develop anti-terrorism treatments and to fully include women in studies will both affect clinical research.
Oct 01, 2001
Applied Clinical Trials
While Health and Human Services builds a comprehensive program to ensure the safety of human subjects, Congress weighs proposals to stiffen the rules.
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