Head of agency’s inspectorate stresses need to invest in new IT infrastructure for manufacturing site inspections. New FDA Inspectional Affairs Council leads the charge.
After two years of burdening its legacy IT infrastructure with stopgap solutions to pandemic inspection travel restrictions, the US Food and Drug Administration is making it a priority to support its inspectorate with new agencywide technology systems.
The FDA’s Office of Regulatory Affairs is emphasizing technology in its fiscal year 2023 budget request, not only to strengthen...
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.
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
