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MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings

Almost one-third of Type IA variation notifications are being rejected by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) due to not meeting the filing criteria or including the right administrative information, according to an assessment by MHRA covering the six months since the new EU variations regulations became effective....

New FDA Draft Guidance Reduces Reporting Burden for CMC Postapproval Changes

A new draft guidance from FDA specifies 40 types of low-risk manufacturing changes that will now quality for annual report filing and represents a significant step in the agency’s effort to reduce the number of supplements that have to funnel through the Center for Drug Evaluation and Research (CDER) clearance process....
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