Tag Archive: cardiovascular

Jan 17

Enrichment Strategies for Clinical Trials

On 14 December 2012, the FDA released the guidance Enrichment Strategies for Clinical Trials to Support Approval for Human Drugs and Biological Products.  The guidance is intended to provide strategies for drug developers to enrich enrollment for responder subjects in both early and pivotal clinical trials.  Often, simply enrolling subjects that have the disease that …

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May 02

Cato Research Canada Celebrates Two Decades of Success in the Drug Development Industry

Over the past 5 years, the life sciences industry throughout Canada, and especially in Québec, has been extensively challenged. Capitalizing on strong relationships built over years with clients and partners has helped Cato Research continue to provide excellent services and weather the industry’s roller coaster ride. On 03 May 2012, Cato Research Canada will celebrate its 20th anniversary with a celebratory wine tasting. You are invited to join us and other industry representatives to talk about the changing climate for pharmaceutical and biotechnology companies in Canada.

Apr 08

New FDA Guidances – March 2011

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in March 2011 (most links go directly to PDF documents). Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act …

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Aug 09

July 2010 FDA Guidances

Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in July 2010 (links go directly to PDF documents). Special Interest Guidances/Information Date Posted Residual Drug in Transdermal and Related Drug Delivery Systems (Draft) 8/02/2010 …

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