The idea of establishing a non-profit governance group to coordinate the package-level tracing of pharmaceuticals through the US distribution chain that DSCSA requires drew widespread support at a May 1 PDSA meeting in Washington, DC. PDSA wants to get the group up and running by October.
A vision is emerging and gaining buy-in across industry sectors that would establish an industry led governance board to help set up an electronic interoperable verification and tracing system for policing counterfeit drugs marketed in the US, due in November 2023 by law.
The plan is for private sector firms that participate in the biopharmaceutical supply chain such as manufactures, wholesalers and distributors...
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.
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.
Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
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.
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
