Jill Wechsler is ACT's Washington Correspondent
Clinical Trials Face New Enforcement Models
FDA eyes risk approaches to site inspections to use resources more efficiently.
Health Reform Supports Biomedical R&D
Pharma will pay new fees and rebates but gain drug utilization and safeguards to innovation.
Regulatory Science to Inform Trial Design
FDA Commissioner Hamburg seeks resources to build agency scientific expertise & new research methods.
Pharma Cheers Health Reform Legislation
Health IT Promises Timely Drug Information
FDA is modernizing systems to better access data on drug effects, utilization, and safety.
Obama Reform Plan Features Curbs on Drug Spending
Science and Research Top FDA Priorities
New commissioner seeks to expand FDA's capabilities to bring safe and effective drugs to patients.
Campaign Grows To Transform Clinical Research
Research Faces Challenges in 2010
Globalization and reform initiatives will take part in shaping biomedical research and clinical studies.
U.S. Departments and Offices
A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.
Safety Requirements Slow New Drug Approvals
FDA reviewers strive to assess new postmarketing programs while also evaluating applications.
FDA Promotes Integrity and Compliance
Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.
Global Development Challenges Sponsors
International health crises expand testing of new vaccines and drug treatments for third-world diseases.
Health Reform Shapes Drug Development
Pressure to reduce health care spending puts R&D, costs, and coverage on the negotiating table.
Safety & Transparency Shape Drug Development
FDA leaders stress innovation and disclosure in promoting the agency's public health mission.
Commissioner Hamburg on Global Drug Regulation and FDA Challenges
Jill Wechsler provides a special report of a briefing with FDA's new commissioner Margaret Hamburg.
Clinical Research Under Scrutiny
Agency officials and sponsors anticipate stiffer oversight of research operations and disclosure requirements.
Comparative Research to Shape Clinical Trials
Government funding slated to boost studies comparing medications to other treatments.
Health IT Offers Both Promise and Problems
Biomedical research community finds privacy policies add cost and complexity to clinical studies.
FDA Update Under the Obama Administration
New leadership and more resources aim to modernize FDA operations.
Transparency Shapes Pharmaceutical R&D
Reformers seek disclosure of investigator payments and conflicts of interest.
Congress Approves Down Payment on Health Reform
The stimulus bill expands the health care safety net while boosting investment in health IT and comparative research.
Health Reform Targets Costs and Coverage
Proposals to reduce outlays for drugs could limit biomedical research and product development.
FDA Faces Challenges and Changes
More resources and new leadership could help FDA regain its stature and bolster support for innovation.
Waxman to Head Key House Committee
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.
Daschle to Spearhead Health Reform Efforts
President-elect Barak Obama selects former Senate majority leader Tom Daschle as secretary of Health and Human Services.
Global Trials Draw Regulatory Scrutiny
FDA is conducting more inspections to ensure that foreign clinical research meets GCP standards.
Orphan Drug R&D Challenges Sponsors
Global harmonization, regulatory flexibility promise to expand treatments for rare and neglected diseases.
Health Reformers Seek Effectiveness Data
Comparative drug analysis aims to address costs and value as candidates eye curbs on drug spending.