Regulatory Focus

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to QOL Medical to “false or misleading” claims made in promotional emails for its congenital sucrase-isomaltase deficiency (CSID) treatment Sucraid (sacrosidase) oral solution.

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices from premarket notification requirements.

During a public hearing on Thursday, the US Food and Drug Administration (FDA) received several suggestions from industry stakeholders on how to improve its Commissioner’s National Priority Voucher (CNPV) pilot program, though several observers were critical of the initiative.

The US Food and Drug Administration (FDA) recently sent warning letters to two facilities in the United States and Mexico for failing to comply with current good manufacturing practices (cGMPs) related to contamination issues and data integrity problems. The agency also warned a company in Brazil for failing to respond to a request for written records and to a laboratory in the US for nonclinical study violations.

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.

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The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are intended to reflect provisions in the 2023 Consolidated Appropriations Act.

The European Commission has adopted a roadmap to phase out the use of animals in chemical safety assessments, including for pharmaceuticals.