...by industry and regulators are heading toward internationally harmonized solutions to the challenges involved. In view of more temperature-sensitive products and a more complex distribution chain, FDA and other regulatory agencies are working to develop and implement effective guidance and oversight in conjunction with industry and pharmacopeia efforts to develop viable, globally-relevant standards. Key temperature control issues include: ** how much monitoring is appropriate ** allowable excursions during transportation, and ** how to qualify the distribution process. [A discussion by an FDA compliance official of the initiative under way at the agency to assess cold chain problems and better target its regulatory response is provided.]
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
