Columns | View from Washington

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.

FDA eyes risk approaches to site inspections to use resources more efficiently.

Pharma will pay new fees and rebates but gain drug utilization and safeguards to innovation.

FDA Commissioner Hamburg seeks resources to build agency scientific expertise & new research methods.

FDA is modernizing systems to better access data on drug effects, utilization, and safety.

New commissioner seeks to expand FDA's capabilities to bring safe and effective drugs to patients.

Globalization and reform initiatives will take part in shaping biomedical research and clinical studies.

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

FDA reviewers strive to assess new postmarketing programs while also evaluating applications.

Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.

International health crises expand testing of new vaccines and drug treatments for third-world diseases.

Pressure to reduce health care spending puts R&D, costs, and coverage on the negotiating table.

FDA leaders stress innovation and disclosure in promoting the agency's public health mission.

Agency officials and sponsors anticipate stiffer oversight of research operations and disclosure requirements.