US FDA sends warning letters to online businesses operating a total of 465 websites selling unapproved Rx drugs for indications including breast cancer, chicken pox and pain relief. Warning letters were part of Interpol's annual Operation Pangea against online sales of illegal medical products; this year, US and 115 other countries made 859 arrests worldwide and seized $14m in potentially dangerous pharmaceuticals.
US FDA isn't the only national drug industry regulator attempting to curb online nonprescription sales of unapproved opioid and other Rx drugs. The violations are so rampant, Interpol is coordinating an annual worldwide crackdown.
Shutting down, or ordering a halt to online businesses selling unapproved opioid and other Rx drugs is part of FDA's...
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.
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.
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 AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
