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  • Regulatory NewsRegulatory News

    FDA Warns of Dosing Errors With Compounded Injectables

    The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors.   "Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently," FDA writes.   For small volume parenteral drugs a...
  • Regulatory NewsRegulatory News

    FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo

    The US Food and Drug Administration (FDA) has agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications of renal cell carcinoma, metastatic melanoma and non-small cell lung cancer.  The modification of the “Dosage and Administration” section of the label replaces “the single dose regimen of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every t...
  • Regulatory NewsRegulatory News

    FDA Adopts, Releases ICH Document on Dose Uniformity

    The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation's (ICH) Q4B guideline on the use of pharmacopoeial texts. Background ICH is a regional harmonization group composed of the US, EU and Japan, as well as other countries which serve in a voluntary capacity. The aim of the group is to allow the regulatory processes of each to better align with those of the others,...