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.’
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
