Tag Archive: nonclinical research

Oct 10

New FDA Guidances for September 2013

September was a big month for CDRH Guidances.  Both the final Mobile Medical Applications Guidance and the much awaited Guidance on the Unique Device Identification Database were released.  More information about the Unique Device Identifier program can be found here. Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration Generic Drug User Fee Amendments …

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Jun 06

New FDA Guidances Released in May 2012

Here’s a list of the  guidances released by FDA in April 2012, compiled by Cato Research Scientist Elinore Mercer, Ph.D. Pediatric Information for X-ray Imaging Device Premarket Notifications (Draft) S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (Draft) …

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May 21

Stem Cells: Which Way to the Clinic? (Updated!)

For over two decades, the potential of stem cell therapy to cure some of our most devastating diseases has been touted by the media.  A Google search of “stem cell research” yields over 57 million results, and yet, in mid-2012, there is only one approved stem cell product on the market in the United States …

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Mar 09

After all the talk, where are we with biosimilars?

Biosimilars

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 process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. …

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Nov 02

Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to lag behind and often do not recognize that project management is not too complex or …

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Jul 28

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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Jun 28

Biotech Funding: Still Playing Hard-to-Get

After a few lean years, biotechs raised $25 billion in 2010.  For the majority of small companies however, funding remains difficult to find.  Ernst & Young’s annual report on the biotechnology industry, Beyond Borders, was recently released and it paints a less rosy picture than the $25 billion number would appear to. It turns out …

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May 09

Conference Recap – 2011 Society of Toxicology Annual Meeting

The Society of Toxicology’s (SOT) 50th Anniversary Annual Meeting was held on 05-10 March 2011 in Washington, DC.  Several members of Cato Research’s Nonclinical Sciences Development group were amongst the more than 7,000 toxicologists from 50 countries in attendance this year.  The five-day event provided scientists with countless opportunities to discuss the latest scientific achievements …

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Oct 26

Vendor Selection – All that Glitters is Not Gold

One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities.  Several variables determine what makes a good outsourcing partner – size compatibility between CRO and sponsor, the cost, and the experience level of the CRO …

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Sep 27

Annual Reports: A Time for Reflection

You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year?  Quite possibly.  In the rush to keep things moving, it’s all too easy to not take the time to pause and get a healthy dose of perspective.  Enter annual reports for drug/biologic development …

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