Jill Wechsler, ACT's Washington Correspondent

Ketek probe raises questions about research oversight by FDA, sponsors, and investigators.

Janet Woodcock is welcomed back as the director of the Center for Drug Evaluation and Research (CDER).

FDA, NIH, and sponsors all struggle to implement complex registration and data access requirements.

The agency's 2008 budget fails to keep up with expanding programs, added safety concerns.

FDA and sponsors implement FDAAA as pressure builds to curb drug prices and tweak the R&D process.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

Information systems and lax enforcement criticized as Congress expands trial disclosure requirements.

Expanded access to drugs for seniors has increased demand, focusing more attention on medical costs.

Congress Approves User Fees, Safety Policies for FDA

Additional testing and monitoring requirements promise many changes for pharma R&D.

Journal editors and legislators expand the scope of clinical trial registration and results disclosure.

High-quality programs needed to protect subjects, improve data, harmonize global trials, and manage costs.

Added information to inform treatment decisions may drive up research costs for sponsors.

Policy makers discuss incentives for trials on children and for generic versions of biotech therapies.

Drug safety concerns, unproductive methods, and high costs encourage innovative study designs and collaborative efforts.

Regulators and sponsors encourage alternative review models to fit a growing research enterprise.

Shift in Congressional control opens door to probes into research practices & expansion of PDUFA legislation.

A changing research enterprise requires clearer policies and more effective regulatory tactics.

Under IOM's plan, a "lifecycle approach" to drug evaluation would change FDA's pre- and postapproval policies.

Confusion over policies governing prisoners points to the need for clear, uniform safeguards for all research.

Rise in foreign studies requires attention to ethical issues, investigator training.

Agency seeks to calm critics by improving subject protection, while also streamlining research oversight.

Payers seek more comparative drug data from sponsors and independent researchers.

The much anticipated list features initiatives in biomarkers and research productivity.

More consultations with sponsors promise to drive drug development, but also impose a growing burden on FDA.

FDA seeks to reduce clinical research failures and make drug labeling more useful.

Drug safety and R&D issues will play a prominent role in user fee program revisions.

Changes prompt new oversight approaches by FDA and research institutions.

While veteran officials keep the agency running, changes continue at FDA's new drug review and safety oversight offices.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.