View from Washington - Applied Clinical Trials

ADVERTISEMENT

pagepush
Find Pharma Search Engine
To read PDF files you need Adobe Acrobat® Reader.
Click here for your free copy.
View from Washington

Real-World Clinical Testing Challenges

May 1, 2012

Expanding access to nonprescription drugs and facilitating comparative effectiveness research.

Transparency, Sunshine Shape Research

April 1, 2012

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

PDUFA Renewal Seeks Development Incentives

March 1, 2012

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

Quality Approaches Key to Transforming Research

February 1, 2012

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

Risk & Resources to Shape Trial Operations

January 1, 2012

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

US Departments and Offices

December 1, 2011

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

Patients, Investigators Seek Flexibility at FDA

November 1, 2011

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

FDA, Sponsors Gear Up for User-Fee Action

October 1, 2011

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

Uniformity Sought for Research Standards

September 1, 2011

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

ADVERTISEMENT

ADVERTISEMENT

Untitled Document
Click here