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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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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CenterWatch Data Library
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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