Sponsors should notify US FDA quickly when they detect data quality issues in preclinical and clinical research, particularly for applications under review, experts say in a rebuke to Novartis’ delayed notification about Zolgensma data manipulation.
Data integrity lapses in preclinical and clinical research can endanger a drug development program and warrant close attention from sponsors as well as early communication with the US Food and Drug Administration, industry lawyers and consultants say.
While data integrity issues in the pharmaceutical manufacturing space, including warning letters and enforcement actions for good manufacturing practice (GMP)...
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Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.
Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.
