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IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

From breaking news to in-depth analysis, International Pharmaceutical Quality places its readers "Inside the Global Regulatory Dialogue"™ where the initiatives that will reshape the landscape are being defined

IPQ's incisive, cutting-edge analysis allows its readers to understand the forces that are driving the industry/regulator dialogue and the emerging solutions that are being proposed. IPQ provides the context and insight needed to respond to and impact these pivotal quality regulatory trends and developments and make informed decisions.

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The News in Depth

FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....

December 28 2014 / Read More

FDA Field Operation 2015 Priorities Include Alignment with Centers and Lab Optimization

Top priorities for FDA’s Office of Regulatory Affairs (ORA) in 2015 include closer functional alignment with the agency’s reviewing centers and a major restructuring and optimization of its laboratory operations....

December 27 2014 / Read More

ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda

The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur....

December 26 2014 / Read More

Updates in Brief

IPQ also provides "Updates in Brief" for its subscribers to alert them to breaking CMC/GMP developments.

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  • “In the News” — breaking stories on our website
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  • “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern
  • Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

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Nov. TOC1_picClick here for the November 2014 Monthly Update

 

IPQ’s Mission:

IPQ is dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.



IPQ takes its readers from:

  • ● the headlines to the forces driving them
  • ● regulations and policies to their underlying intent
  • ● the pieces of the puzzle to their interconnection
  • ● requirements to implementation pathways
  • ● random data to critical trends
  • ● the sidelines to helping shape the outcome
  • ● compliance problems to proactive quality tools
  • ● information to intelligence

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Subscribe today and get 24/7 access to the IPQ family of publications: In the News — breaking stories on our website; Weekly News Alert — sent via email; Monthly Update — the key CMC and GMP developments in the US, Europe and internationally; Special Reports — in-depth analysis of specific, emerging issues of regulator/industry concern; and Documents and Archives — live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library.



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Bill Paulson:
IPQ Editor-in-Chief

Before launching IPQ, Bill served for over two decades as the primary author of “The Gold Sheet.” During his career tracking the drug and biotech quality regulatory process, Bill's identification of key issues and problem areas and emerging solutions has been influential in the targeting of resources by industry and FDA and has impacted the dialogue on the shaping of new CMC and GMP policies. More about About Bill Paulson

 

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