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New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.
Latest From Manufacturing
Another day, another report on how to tackle the ever-present problem of antimicrobial resistance and the dearth of new treatment. In its latest assessment of the state of play, the AMR Industry Alliance has come up with some alarming facts and figures – and some ideas for the next steps.
US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.
2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.
Companies seeking approval of new drugs must provide information on nitrosamine-related risk evaluation either as part of their marketing application or during the evaluation process.
Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.
Agreement will help save inspection resources at Swissmedic and South Korea’s Ministry of Food and Drug Safety.
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