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As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.
Latest From Manufacturing
Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotides and peptide drugs. They say that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these products, which have flooded the development pipeline.
'Knowledge management platform' will identify agency's scientific precedents; Commissioner Gottlieb says it is one of FDA's top three initiatives, along with continuous manufacturing and real-time safety monitoring.
Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement.
Solicitor General to weigh in on Gilead's petition asking court to clarify application of its Escobar decision; PhRMA and BIO say FDA, not jury, should decide whether company has complied with FDCA.
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