A planned program to accredit third-party laboratories for food safety inspection is "particularly valuable ... with regard to foreign manufacturers, where FDA is unable to inspect [them] on any kind of regular basis," according to Assistant Commissioner for Food Protection David Acheson
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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.’
New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.
Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
