Lyne Laboratories of Brockton, Mass., was cited for inadequate lab controls in a Jan. 17 warning letter. The firm, a contract manufacturer of oral liquids, powders, semi-solids, tablets and liquid dose unit-dose packaging, was cited for failing to thoroughly review the failure of a batch or any of its components to meet specifications. FDA said the company has not completed an investigation into the chemical composition and potential patient risk for particulate matter found in its Calcitriol Injection. The firm was also cited for failure to establish adequate laboratory controls including scientifically sound and appropriate test procedures to assure that drug product components and drug products conform to appropriate standards of identity, strength, quality and purity
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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.
