Woodcock: The US FDA Sets The Stage For Global Quality Dossiers
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
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Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.
FDA announces the rollout of a pilot program with industry to exchange data on quality specifications for the Common Technical Document’s Module 3. The agency plans to exchange data on other portions of the CTD’s quality section later this year. The data exchange would largely replace the “hunting and pecking” for information in PDFs that reviewers have to do to locate quality information in NDAs and ANDAs.
Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.