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IPQ Monthly Update – October / November 2016 in Review

In October and November, IPQ was focused heavily on the experience and learnings FDA has gained in the first five years of its biosimilars review program and the improvements that the agency and industry want to see happen with user fee help in moving forward. Also in focus in the international section of the Update are: ● advancing and harmonizing other aspects of the biotech product CMC review process, including accelerated pathways, and ● the current pressure and incentives to apply QRM to excipients.

Combination Product Regulatory Improvements Remain High on Pharma’s 2017 Wish List

Clearer, more review/inspection coherent, more risk-based, and more harmonized regulatory expectations across the expanding universe of drug/device combination products will continue to be a high-priority focus for the pharmaceutical industry during 2017.

Focus Intensifying in Europe on Improving Drug/Device Combination Product Regulatory Communication

The challenges of the CMC regulatory process for drug/device combination products are getting increasing attention in Europe as industry and regulators join in the search for clearer and more efficient communication channels and regulatory procedures.

IPEC Leaders Tout Benefits of Documented Risk Assessments Called for in Recent Industry and Regulator Excipient GMP Standards

IPEC leaders are touting the multilayered benefits to excipient manufacturers and their pharma customers of establishing and documenting the more formal risk assessment processes called for in the recent industry and regulator excipient GMP standards.

CDER’s Office of Biotechnology Products Sheds Light on Biosimilar CMC Challenges and Solutions

While cautioning industry that developing a biosimilar remains a challenging marathon, FDA’s Office of Biotech Products (OBP) is now able to offer a lot more concrete advice on what it takes to cross the finish line.

User Fee Reauthorization Prompts More Intensive FDA Assessment of Its Growing Biosimilar Regulatory Experience

The Biosimilar User Fee Act (BsUFA) reauthoritization process has driven an intensive assessment by FDA of its growing body of regulatory experience to determine where the difficulties have been in the first five years of the user fee program and what can be done to address them.

Impact of Accelerated Pathways on Method Development, Inter-Agency Collaboration Draw Regulator Discussion at Europe Biotech CMC Strategy Forum

The impact of accelerated clearance pathways on the deployment of the analytical method toolbox for biotech products is among the issues drawing attention at industry/regulator conferences where the CMC challenges and the experience to date in accelerated review are being discussed.

IPQ Monthly Update – August / September 2016 in Review

In focus are: ● the concerns biotech product regulators in the U.S. and Europe are raising during their CMC and inspection reviews and the ongoing efforts to facilitate the development and clearance process ● the excipient/material issues that are surfacing in reviewing new drug delivery systems and how FDA’s inactive ingredient database (IID) can help, and ● how the vision of mutual inspection reliance between the U.S. and Europe is taking shape.

Review/Inspection Control Strategy Communications Key in Advancing Biotech Regulation, FDA Biotech Official Stresses

Biotech product and process knowledge has created the foundation for regulatory changes, but close communication and coordination between manufacturers and regulatory agencies will be necessary to realize those changes while ensuring and advancing product quality, FDA Center for Drug Evaluation and Research (CDER) Office of Biotechnology Products (OBP) Review Chief Sarah Kennett emphasized at the […]

Protein Sequence Variants, Process Development and Spec Setting Are Generating Queries from EU Biopharmaceutical CMC Assessors

Protein sequence variants have been generating more questions among European CMC regulators in reviewing monoclonal and recombinant product dossiers – joining process development/validation and specification setting as areas where they are often not finding what they need to complete the review.
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