Category Archive: Industry News

Jul 09 2012

Unique Device Identifiers: It’s the Law, Almost

When the FDA Amendments Act was signed into law in 2007, one of its many tasks was to create a Unique Device Identifier (UDI) system.  On 03 July 2012, the FDA released the proposed rule for UDIs. The UDI is a code, similar in theory to a barcode, that will be printed on each device …

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Jun 25 2012

Clinical Trials in the Facebook Age

On 07 Jun 2011, Pfizer initiated a clinical trial pilot to assess safety and efficacy of Detrol LA, which is a treatment for overactive bladder (OAB).  The trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience), was the first completely “virtual” trial ever designed.   The trial was set-up to compare if a completely virtual …

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Jun 12 2012

PET Drugs – Time to file that NDA, ANDA or IND

No more Nice Guy.  FDA is stopping Enforcement Discretion for facilities producing positron emission tomography (PET) drugs for clinical use effective Tuesday, 12 June 2012. The long and tortured history of PET Drug products regulation began in 1997, when Congress passed the Food and Drug Administration Modernization Act (FDAMA).  One of the sections in this …

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Jun 08 2012

Warning: Your “Check CAPA” Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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Jun 08 2012

Warning: Your “Check CAPA" Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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Jun 06 2012

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 25 2012

PDUFA V: A Funny Sounding Name for a Very Important Bill (Updated!)

US Capitol

Can you say PDUFA (pŭ-dōō-fŭ)?  The United States Senate can.  A very partisan Senate showed uncharacteristically bipartisan support for the Prescription Drug and User Fee Act (PDUFA) V, voting on 24 May 2012 to reauthorize PDUFA by a 96 to 1 vote.  This reauthorization allows for a 6% increase in fees paid by drug and …

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May 21 2012

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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May 02 2012

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.

May 02 2012

Across the Board Disqualifications for Clinical Investigators

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

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