CHPA supports improving the compendial test methods and establishing product standards for the variety of dosage forms, which can provide an additional measure of safety for OTC products.
CRN, CHPA, and their member companies are concerned with and offer the following comments to the proposed revisions to the USP-NF General Chapter <467> on Residual Solvents.
Our member companies support the concept that well-designed metrics are critical in driving and measuring continuous improvement activities in both quality systems and improving manufacturing processes.
CHPA appreciates the opportunity to provide information relevant to the assessment of the evidence of the potential developmental neurotoxicity of fluoride.
CHPA is generally supportive of the revision proposal to update and clarify the Chapter. We would however request that the implementation be delayed for 24 months.
CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.
FDA intends to expand the scope of Redbook to include chemical safety assessments for all products over which FDA's Center for Food Safety and Applied Nutrition has statutory authority. We urge FDA to provide clear and specific guidance for applying these principles within each particular context.
