Jill Wechsler, ACT's Washington Correspondent

Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans.

Multiple proposals for streamlining research emerge in legislation, expert reports.

Expanding access to nonprescription drugs and facilitating comparative effectiveness research.

Demand for more information on study results and investigator payments create challenges.

Congress, industry map out goals and concerns for revising FDA policies linked to user fee legislation.

The FDA issued guidances in February that outlines its recommendations for developing and approving biosimilar therapies.

FDA wants sponsors to build quality into protocols, adopt risk-based strategies to streamline trials.

Pressure to approve new user fees will affect policies for foreign studies and research methods.

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

Challenge to coverage mandate would undermine efforts to achieve universal coverage.

Alternative approaches aim to tackle drug shortages, spur orphan drug development.

Multiple regulatory and reimbursement proposals are slated to expand legislation to renew PDUFA.

Modernizing the Common Rule to update research policies could spell important changes.

Pharmaceutical testing and production overseas spurs call for more reliance on counterparts.

Debate narrows over extent of pre-clinical and clinical testing for follow-on versions of complex biologics.

CER funding boosts agency informatics initiatives that promise to modernize research and review processes

FDA, NIH, industry seek new strategies to support drug development, revive pharma pipeline.

Presidential panel to examine need for tighter rules governing US and foreign clinical trials.

FDA's Sentinel Initiative sets pace for tapping e-health records for product assessment.

Congress readies probes of FDA practices, while FDA seeks transparency and organizational changes.

New user fees, health initiatives, and FDA compliance concerns are top issues for 2011.

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

PCORI, methods panel to set policies for comparing drugs and medical products and practices.

Reform law requires tracking and disclosure of fees to investigators and research consultants.

Sponsors, health care providers weigh pros and cons of REMS for bringing risky products to market.

Inspector General study focuses attention on quality of data and patient safeguards.

More information may be available on drug applications to expand public understanding of FDA policies.