Center for Drug Evaluation and Research

Society for Clinical Research Sites launches as voice of site community in shaping research enterprise

Sunday, October 14, 2012 07:00 AM

Clinical research sites now have their first-ever trade group.

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Quest Diagnostics

Vince & Assoc. awarded $5M FDA contract to conduct clinical studies

Wednesday, September 26, 2012 10:21 AM

Vince & Associates Clinical Research, a clinical research services company based in Overland Park, Kan., has been awarded a contract with the FDA’s Center for Drug Evaluation and Research (CDER) to conduct bioequivalence studies of innovator and generic drugs such as anti-epileptic drugs.

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New executive committee named to CTTI

Friday, September 7, 2012 02:08 PM

The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

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FDA approves first drug formulated for children with rare brain tumor

Monday, September 3, 2012 08:25 AM

The FDA has approved Novartis’ Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor used to treat subependymal giant cell astrocytoma (SEGA, a rare brain tumor).

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Report: FDA strengthens monitoring of post-approval drug safety

Monday, April 23, 2012 10:19 AM

A strengthened and modernized post-market drug safety program has resulted in a substantial improvement in the FDA’s oversight of drugs once they reach the American public, according to a new report by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to post-market drug safety monitoring as to premarket drug review.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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