In general, CHPA supports FDA's intent to harmonize the requirements for Rx and OTC products and make them consistent with long-standing Agency policy.
Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request", published as Draft Guidance.
Enclosed herein are comments on "Guidance for Industry; Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE determination Under the Sunscreen Innovation Act."
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.
CHPA appreciates the opportunity to provide information relevant to the assessment of the evidence of the potential developmental neurotoxicity of fluoride.