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FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....

Fear-based Relationships Antithetical to Progressing Quality Systems, While Measurement is Key, CDER’s Woodcock Stresses at ISPE Metrics Forum

The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing....

EMA Work Program 2015-2016

In mid-December, the EMA Management Board adopted a work program and budget for 2015, as well as a draft program and budget for 2016. The priorities decided upon include facilitating/enhancing: ● quality, regulatory and scientific consistency in assessments ● early stage development of human and vet medicines ● international cooperation within Europe and internationally ● […]

CDER MAPP for Chemistry Review of QbR Submissions

A Manual of Policy and Procedures (MAPP) for Chemistry Review of Question-based Review (QbR) Submissions was released in mid-November. The MAPP clarifies how reviewers in OPS should assess NDAs and ANDAs that follow a QbR format. The document lists the benefits that come from using a QbR approach, and in the appendix, the 62 questions […]

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....

CDER’s Office of Pharmaceutical Quality Will Become Functional in January Following Commissioner’s Call for Commodity-Oriented Center/Field Alignment

The initiatives underway at FDA’s Center for Drug Evaluation and Research (CDER) that its new Office of Pharmaceutical Quality (OPQ) will help drive include expertise-based team reviews, closer review/inspection alignment, an auditable quality management system (QMS), a comprehensive pharmaceutical quality IT platform, and new preapproval and surveillance inspection approaches....

FDA MAPPs Revised Based on PDUFA V

FDA issued revised MAPPs on review timelines and approval information in mid-August to adjust for changes stemming from PDUFA V. Notably, the MAPPs state that information will now be available online, generally three days after approval. CDER agreed in the reauthorized user fee act to notify applicants of planned review timelines for new NDAs, BLAs, […]

MAPP on Breakthrough Therapies

A Manual of Policies and Procedures (MAPP) was released by FDA in late July describing the policy, roles, and responsibilities of CDER’s review staff, CDER/sponsor interactions and communications, and review time lines for the management of breakthrough therapy-designated drugs. The MAPP is intended to facilitate and expedite development and review of IND submissions for breakthrough […]

Johns Hopkins, UCSF-Stanford Tagged as FDA Centers of Excellence

In early May, FDA designated Johns Hopkins University and the University of California at San Francisco-Stanford University as “Centers of Excellence in Regulatory Science and Innovation” (CERSI), joining the University of Maryland and Georgetown University. The centers receive support from the agency to “promote cross-disciplinary regulatory science training, scientific exchanges, and leading-edge research focused on […]

EMA Issues 2013 Annual Report

In late April, EMA published its 2013 annual report, which notes the recommending of 81 medicines for approval for human use, compared to 57 in 2012. The annual report also highlights some of the initiatives and achievements from 2013, including its implementation of the Falsified Medicines Directive (see IPQ July 29, 2013).
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