Tag Archive: inspections

Jan 11 2013

FDA’s Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

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Jan 11 2013

FDA's Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

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Aug 15 2012

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 27 2012

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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May 26 2011

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals.

Jul 08 2010

OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)

There are no foreign lands.  It is the traveler only who is foreign. – Robert Louis Stevenson Global.  That’s one of the buzz words/ideas that has gripped modern drug development.  In particular, there is a notion that foreign countries represent some unblemished Eden where clinical trials can be run cheaper and faster than in the …

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Apr 29 2010

Slides from “Planning for FDA Clinical Site Inspections” Webinar

Earlier today, Cato Research Regulatory Scientist Cathy Anderson hosted a webinar titled, “Planning for FDA Clinical Site Inspections: Are You at Risk?”  Those who attended got some great practical advice, along with some real world examples of what can go wrong when you’re not properly prepared for a FDA inspection. The slides from Cathy’s presentation …

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Apr 29 2010

Slides from "Planning for FDA Clinical Site Inspections" Webinar

Earlier today, Cato Research Regulatory Scientist Cathy Anderson hosted a webinar titled, “Planning for FDA Clinical Site Inspections: Are You at Risk?”  Those who attended got some great practical advice, along with some real world examples of what can go wrong when you’re not properly prepared for a FDA inspection. The slides from Cathy’s presentation …

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Apr 16 2010

Free Webinar – Planning for FDA Clinical Site Inspections

Join Cato Research for a free educational webinar on Thursday 29 April 2010 at 2PM EST. Cato Research Regulatory Scientist Cathy Anderson will be presenting “Planning for FDA Clinical Site Inspections: Are You at Risk?” Topics covered will include: Responsibilities of FDA, sponsors, and investigators FDA site selection: triggers for inspections Inspection preparation and management …

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