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  • Regulatory NewsRegulatory News

    FDA to Test out New Standardized Medical Device Labels in Proposed Study

    The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling with the use of new content and format standards now under development. Background At present, there are no regulations defining a standardized approach for how content should be structured or formatted for medical devices. This is considerably different than the requirements for other FDA-regulated products, such as food or pharmaceutical products, which must adhere to...
  • New Bill Would Standardize Package Inserts

    A new bill introduced in the Senate on 22 May would require the US Food and Drug Administration (FDA) to propose new regulations regarding the Patient Medication Information (PMI) received by patients. The proposed legislation, S.3212- Cody Miller Initiative for Safer Prescriptions Act , was introduced by Sen. Kristen Gillibrand (D-NY), and deals with PMI patients receive when obtaining drug products from a physician or pharmacist. PMI commonly includes package inser...
  • FDA Calls for Proposed Industry Labeling Standards

    The US Food and Drug Administration is proposing to study how to best standardize medical device labeling by polling healthcare providers and is calling on industry to generate recommended labeling formats and contents. FDA opened a comment period on the proposed study back in November 2011, and received comments from industry group AdvaMed questioning the utility of the study, the accuracy of the estimated burden, the validity of the methodology and the subject to be ...