A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.
The closed-circuit television footage referenced in the Form 483 report was clear: something FDA investigators weren’t supposed to see was going on at Hetero Labs Ltd.’s drug manufacturing facility in Polepally Village, India.
But much about the video remains unclear to those who later read the Dec
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
