US FDA official outlines a number of issues around data integrity lapses, including how they trigger concern around all records of a non-compliant firm and that certain factors, including the limited oversight of sponsors over CMOs, could potentially be linked with data integrity problems.
Data integrity underpins basic cGMP principles and breaches could therefore cast doubt on all results and records, especially with regulators not knowing how much is “unknown or still hidden.”
Carmelo Rosa, Director, Division of International Drug Quality at the US FDA's Center for Drug Evaluation and Research, noted at...
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The UK’s autumn budget failed to introduce any widespread changes for pharma, but scale-ups and innovators could benefit from changes to enterprise and investment schemes. Some industry voices warn of underinvestment in the MHRA and innovative medicines.
The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.
A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.
New Zealand is also lifting its prohibition on advertising unapproved medicines at medical conferences and trade shows in order to boost its appeal as a host for such events and generate millions of dollars in revenue.
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
