
FDA eyes risk approaches to site inspections to use resources more efficiently.
Jill Wechsler is ACT's Washington Correspondent

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.

Jill Wechsler provides a special report of a briefing with FDA's new commissioner Margaret Hamburg.

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

Government funding slated to boost studies comparing medications to other treatments.

Biomedical research community finds privacy policies add cost and complexity to clinical studies.

New leadership and more resources aim to modernize FDA operations.

Reformers seek disclosure of investigator payments and conflicts of interest.

The stimulus bill expands the health care safety net while boosting investment in health IT and comparative research.

Proposals to reduce outlays for drugs could limit biomedical research and product development.

More resources and new leadership could help FDA regain its stature and bolster support for innovation.

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

In a sharp break with Washington tradition, Rep. Henry Waxman (D-Calif) unseated long-time top Democrat on the House Energy & Commerce Committee, John Dingell (D-Mich), to become the panel's new chairman.

President-elect Barak Obama selects former Senate majority leader Tom Daschle as secretary of Health and Human Services.

FDA is conducting more inspections to ensure that foreign clinical research meets GCP standards.

Global harmonization, regulatory flexibility promise to expand treatments for rare and neglected diseases.

Comparative drug analysis aims to address costs and value as candidates eye curbs on drug spending.