View from Washington - Applied Clinical Trials

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View from Washington

Safety Requirements Slow New Drug Approvals

November 1, 2009

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

FDA Promotes Integrity and Compliance

October 1, 2009

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

Global Development Challenges Sponsors

September 1, 2009

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

Health Reform Shapes Drug Development

August 1, 2009

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

Safety & Transparency Shape Drug Development

July 1, 2009

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

Clinical Research Under Scrutiny

June 1, 2009

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

Comparative Research to Shape Clinical Trials

May 1, 2009

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

Health IT Offers Both Promise and Problems

April 1, 2009

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

Transparency Shapes Pharmaceutical R&D

March 1, 2009

Reformers seek disclosure of investigator payments and conflicts of interest.

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