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The News in Depth

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.

More Clarity Sought in FDA’s Inactive Ingredient Database Regarding Drug Delivery Devices

FDA and the excipient industry are giving more thought to how the inactive ingredient database (IID) can be improved to better support the development of emerging dosage forms, including drug delivery devices such as transdermal patches, metered dose inhalers, nasal sprays, and implants.

Goal of FDA/EU Mutual Inspection Reliance is Nearing Realization

FDA and the EU have made significant progress down the long and winding road of formalizing an agreement to rely on each other’s drug GMP inspections.

Procedures, Eligibilities and Goals of EMA’s Accelerated Access Efforts Are Taking More Concrete Shape

The procedures, eligibilities and goals of EMA’s accelerated access approaches for new medicines that fill unmet medical needs, including “Priority Medicines” (PRIME) and “Adaptive Pathways” (AP), have been taking more concrete shape, informed by the European agency’s growing implementation experience.

IPQ Monthly Update – June / July 2016 in Review

In focus are the active discussions now going on between industry and regulators on: ● the role that knowledge management can play in evolving the lifecycle quality regulatory paradigm ● how to make the agency’s inactive ingredient database (IID) as accurate and useful as possible, and ● how regulators are refining their expectations and guidance around data integrity based on their inspection experience, and what companies should be doing, in turn, to uncover, fix, and prevent data integrity problems.

FDA Efforts Continue to Make its Inactive Ingredient Database More Functional

FDA’s Office of Pharmaceutical Quality (OPQ) is sharpening its vision of how to increase the reliability and user input in its Inactive Ingredient Database (IID) to make it more beneficial to both internal and external users.
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