Jill Wechsler, ACT's Washington Correspondent

Congressional efforts to establish a Medicare pharmacy benefit will affect R&D, and a new FDA commissioner promises change.

The agency is shifting regulation of biotech therapies to its drug center, a streamlining initiative to be implemented by a new FDA commissioner.

Federal agencies seek to enhance IRB operations as new policies further expand board responsibilities.

Although a Medicare drug benefit appears unattainable this year, Congress is considering other measures to reduce the cost of medicines.

PDUFA III boosts manufacturer fees to expand postapproval surveillance and support new FDA review initiatives.

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.

Rules to ensure confidentiality of individual health information threaten to make clinical trials more complex and costly.

Federal prosecutors target sponsors and clinical investigators who misuse federal funds or violate research requirements while FDA proposes new policies and Congress eyes reforms.

Human research protection takes a back seat, as the White House boosts funding for NIH and FDA?along with FDA user fees.

FDA is revising policies to ensure that clinical studies generate sufficient data to ensure the safe use of new medical products.

A proposed policy on Data Monitoring Committee functions and operations raises important issues about the conduct of studies and the evaluation of data.

Efforts to ensure the safety and integrity of clinical trials will generate new standards and expand oversight initiatives.

Efforts to develop anti-terrorism treatments and to fully include women in studies will both affect clinical research.

While Health and Human Services builds a comprehensive program to ensure the safety of human subjects, Congress weighs proposals to stiffen the rules.

As the public clamors for early access to promising new drugs, sponsors worry about the consequences of experimental therapy conducted outside of controlled trials.

As the debate on clinical research policy continues, FDA is setting standards for pediatric studies and encouraging more sex-specific analysis of clinical data.