Search results for " postapproval"
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Efforts Accelerate to Streamline Postapproval Change Process
With more breakthrough and critical therapies gaining fast approval based on limited data and manufacturing experience, more postapproval changes are needed to increase batch size, shift to a new manu…
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Quality Systems Key to Lifecycle Drug Management
There’s renewed support for developing an international quality standard for regulating postapproval changes. And new policies and procedures at FDA aim to streamline oversight of manufacturing change…
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Regulatory Challenges in the QbD Paradigm
Many postapproval supplements introduce new filling lines and manufacturing sites for similar processes. In a QbD paradigm, the regulatory burden is low because there are wider ranges and limits based…
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Breakthrough Drugs Raise Development and Production Challenges
…ferral of Phase III studies to post approval, and the need for comparability protocols to facilitate postapproval changes. Communication with FDA is important throughout the breakthrough development …
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A Look Ahead at BioPharma Manufacturing and Regulation
For regulators, it potentially means less regulatory oversight postapproval due to regulatory flexibility (e.g., design space) filed with the application. FDA is currently pursuing additional pathways…