Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.
The US Food and Drug Administration needs to make sure a backlog of overdue surveillance inspections that has been growing due to COVID-19 travel restrictions does not compromise its ability to conduct “high-risk” inspections going forward, a Government Accountability Office official says.
The agency also should more fully explore the use of alternatives to the on-site inspections the pandemic prevents it from...
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While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
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.
