Guidance on production reporting and on facility switching are part of the agency's new searchable quality guidance listing.
An update on schedules, processes and recommended deadlines for annual drug production volume reports was among the items the US Food and Drug Administration’s Office of Pharmaceutical Quality recently added to its new searchable listing of various types of guidance documents.
The final drug production volume reporting guidance features relaxed deadlines, reflecting the difficulties pharmaceutical manufacturers and the FDA have faced...
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.’
Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.
Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
