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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....

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....

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....

New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum

The Center for Drug Evaluation and Research (CDER) is working to update its biotech inspection compliance program to make better use of the process, product, and compliance information it has collected from the industry in the decade since the previous version went into effect and better target its inspection efforts....

IPQ Monthly Update, November 2014

In focus are the structure, function and impact of two components of the new Office of Pharmaceutical Quality that will be on the front line of its industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management. Included on the international front are stories on: ● how the Europe-based association APIC is mapping API requirements in emerging countries and working with them to make their processes more effective and user friendly, and ● IPEC’s efforts to narrow the excipient maker/user communication gap on visible particles....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

IPEC Seeks to Improve Excipient Maker/User Communications on Visible Particles

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is spearheading an effort to strengthen the communication pathway between excipient makers and users about the significance of benign visible particles in excipients....

FDA’s New Office of Program and Regulatory Operations Will Assume Pivotal Role in CMC Review

FDA’s Office of Program and Regulatory Operations (OPRO) – part of the new Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) – will be responsible for co-leading and facilitating the review of the quality portions of new and abbreviated new drug applications (NDAs/ANDAs)....

CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections

The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....

IPQ Monthly Update, October 2014

In focus are: ● the structure/function changes FDA is making to help drive a new pharmaceutical quality regulatory paradigm with closer center/field alignment ● the role that the new Office of Pharmaceutical Quality will play in steering the various significant initiatives that are now in motion, and ● the implementation challenges presented by the new ICH guidelines on elemental impurities (ICH Q3D) and mutagenic impurities (ICH M7), respectively....
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