Comments regarding Citizen Petition from Greenberg Traurig requesting that FDA issue the administrative order for OTC external analgesics, and that FDA confirm and clarify for which specific indications OTC external analgesic drug products in patch/plaster/poultice dosage forms are generally recognized as safe and effective.
CHPA believes that FDA’s issuance of the 2022 Draft Guidance is premature. Instead, FDA’s priority should be on finalizing the 2016 Draft NDI Guidance and clarifying unanswered questions about the scope and applicability of the NDI notification requirement.
CHPA appreciates the opportunity to provide feedback on the notice requesting comments on the Inactive Ingredient Database (IID). Responses to each of the questions listed by FDA in the March 22, 2022 notice are provided.
CHPA supports efforts to harmonize the current Quality System Regulation with international quality management system requirements. However, CHPA recommends that FDA address several points of concern or clarification when finalizing the Proposed Rule.
CHPA supports the withdrawal or repeal of this rule, as it risks misplaced prioritization of focus by agencies within HHS, leads to workload challenges, and exacerbates problems and backlog in the rulemaking process.
CHPA welcomes FDA’s efforts to modernize and streamline the process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.
CHPA’s argues both constitutional precedent and federal rules on class action lawsuits require classes that capture members who actually have a viable claim and potential right to recovery; not classes in which some consumers are even plausibly harmed.