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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.

Aug 10, 2022

CHPA believes that FDA’s issuance of the 2022 Draft Guidance is premature.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.

Jul 19, 2022

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.

Jun 21, 2022

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.

May 24, 2022

We drafted position statements across five key topic areas in digital health. The position statements are aligned to CHPA’s five key pillars of digital health, which have been validated by members.

Feb 17, 2022

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.

Dec 22, 2021

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process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.

Nov 23, 2021

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.

Sep 7, 2021

PCPC and CHPA appreciate the opportunity to comment on FDA Notice of Intent to Prepare and Environmental Impact Statement to evaluate environmental effects for marketing certain OTC sunscreen products.

Jun 14, 2021

In keeping with the mission of the FDA Center for Drug Evaluation and Research’s Office of Surveillance and Epidemiology Division of Medication Error and Prevention Analysis, this CHPA member feedback is designed to minimize the risk of medication errors due to consumer confusion attributed to an OTC drug product name.

Jun 14, 2021

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