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The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs — an effort aimed at improving the quality and availability of basic medicines. Read More
Argentina has agreed to open its borders to finished drug products from India, giving drugmakers on the subcontinent access to a multibillion dollar market. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather in stages, which is the current policy. Read More
Drugmakers operating in Brazil must report all supply chain movements to Anvisa in real time, according to new guidance on the agency’s drug tracking and tracing system. While the system has broad industry support, an attorney familiar with it says it doesn’t address concerns with biosimilars. Read More
The Therapeutic Goods Administration is seeking feedback on a new system that will let drugmakers submit applications electronically, as the agency prepares to fully adopt the software next year. Read More
Proposed changes to drug labeling regulations that could save the Australian government up to US $30 million annually in hospital admission costs attributed to medication errors, according to the Therapeutic Goods Administration. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is seeking suggestions on prescription drugs that would be exempt from EU safety authentication requirements and nonprescription drugs that should bear the safety feature. Read More