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FDA Deploys Risk Ranking Process to Streamline ANDA Review

FDA’s generics office has developed a risk assessment algorithm for the review of abbreviated new drug applications (ANDAs) to help address the challenges of balancing more extensive quality-by-design-based submissions with the foreshortened review timelines mandated under the Generic Drug User Fee Act (GDUFA)....

FDA Requests Regulatory Research Proposals

In late May, FDA issued a solicitation for research proposals into improving the drug review process. Included in the request for research proposals on: ● ensuring FDA readiness in evaluating innovative emerging technologies ● new approaches to improve product manufacturing and quality development ● post-market evaluation of generic drugs, and ● the development of new […]

ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe

The effort in Europe to update its expectations for process validation (PV) to reflect the quality management principles underpinning ICH Q8-11 moved closer to completion in late February with the issuance of a final guideline on PV submissions for medicinal products and a draft revision of EU GMP Annex 15....

EMA Issues Concept Paper for Revised Immunogenicity Guideline

EMA issued a concept paper in late February revising its immunogenicity assessment guideline. The aim of the revision is to clarify how immunogenicity data is presented, to introduce a risk-based approach, and to determine the appropriate studies needed for different products. [For a discussion of the quality/immunogenicity relationship, see IPQ January 9, 2014.]

Top Analytical Method Problems in INDs and BLAs Include Not Enough Detail for FDA Replication and Inadequate Suitability Controls

Insufficient detail to allow FDA to replicate an analytical method, and failure to include appropriate system suitability controls, are two prominent analytical method problem areas that FDA is finding in reviewing investigational new drug (IND) and biologic license application (BLA) submissions....

CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development

Initiatives that will be on the front burner at the Center for Biologics Evaluation and Research (CBER) over the next year include: ● the completion of an electronic export certification system ● the increased use of databases to identify and confirm adverse events with vaccines and blood products, and ● using its extensive laboratory facilities and expertise to help in the development of novel products....

EDQM Amends CEP Submission and Revision Process; Starting Materials Remain at Issue; Risk-Based CEP Inspection Approach is Finding Problems

A revised process for amending or renewing certificates of suitability (CEPs) put in place by the European Directorate for the Quality of Medicines and Healthcare (EDQM) mandates that some major changes previously filed as revisions will now require applying for a new CEP. The revised process went into effect on September 1....

FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement

FDA’s Center for Drug Evaluation and Research (CDER) is wrestling with how to reshape its quality regulatory system to foster rather than impede continuous improvement across the lifecycle of a process....

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

EMA Guidelines on Process Validation Filings for Biotech Substances and Drug Products Advancing Along with GMP Annex 15 Revision

A guideline on what the European Medicines Agency (EMA) wants to see in marketing authorization applications (MAAs) regarding process validation for biotech drug substances is advancing as a third prong in the agency’s effort to strengthen its PV guidance portfolio....
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