Substantial revision of 2007 DEG guidance comes after hundreds of deaths in seven countries that were linked to diethylene glycol and ethylene glycol adulteration. All containers and all lots of certain additional excipients must now be tested, and many others should be.
The US Food and Drug Administration has expanded its guidance on testing certain medicines for diethylene glycol to also test for ethylene glycol, and to test an open-ended list of additional excipients for the deadly adulterants.
The 9 May revision comes after more than 300 people in seven countries, most of them small children, died from...
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Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
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.
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.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
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.
