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.’
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
