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New FDA Guidances from April 2012

Ask-Cato.com Contributor — Mon, 07 May 2012 18:35:02 +0000

Here's a list of the notable guidances released by FDA in April 2012. Continue reading →

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

Ask-Cato.com Contributor — Wed, 02 May 2012 17:57:36 +0000

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. Continue reading →

Across the Board Disqualifications for Clinical Investigators

Ask-Cato.com Contributor — Wed, 02 May 2012 17:13:58 +0000

The FDA issued a final regulation earlier this week (April 30th) that broadens the rules for clinical investigator disqualifications. Continue reading →

New FDA Guidances Released in March 2012

Ask-Cato.com Contributor — Mon, 09 Apr 2012 17:29:41 +0000

Here’s a list of the notable guidances released by FDA in March 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Direct-to-Consumer Television Advertisements … Continue reading →

Senator Hagan’s TREAT for Small Biotech

Ask-Cato.com Contributor — Tue, 20 Mar 2012 16:27:10 +0000

Image via www.dog-paw-print.com Beginning with the Pure Food and Drugs Act of 1906, legislation proposed by Congress has constructed and continues to modify the FDA. By extension this legislation represents the rulebook that biotech plays by in its pursuit of … Continue reading →

After all the talk, where are we with biosimilars?

Ask-Cato.com Contributor — Fri, 09 Mar 2012 15:55:58 +0000

In this highly charged political climate, no news broadcast is complete without some mention of healthcare. Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval … Continue reading →

The CED Life Science Conference and Biotech’s Yellow Brick Road

Ask-Cato.com Contributor — Thu, 23 Feb 2012 16:30:44 +0000

The 21st annual CED Life Science Conference achieved its mission of cementing the Research Triangle Park as a hotbed for innovation and opportunity in biotech. The 2012 CED LSC showcased local leaders like Victor Dzau, President and CEO of Duke … Continue reading →

New FDA Guidances – December 2011/January 2012

Ask-Cato.com Contributor — Mon, 20 Feb 2012 19:01:33 +0000

Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be … Continue reading →

FDA Issues New PDF Specifications

Evan Richardson — Tue, 03 Jan 2012 16:21:06 +0000

In the chaos of the holidays, you might have missed the release of an important new guidance from FDA. On 20 December 2011, FDA issued version 3 of “FDA Portable Document Format (PDF) Specifications,” fulfilling a promise made at the … Continue reading →

Fifth China Medicinal Biotech Forum – Conference Recap

Ask-Cato.com Contributor — Tue, 29 Nov 2011 18:57:55 +0000

I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading →