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CHPA submits these comments on FDA’s Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products; Draft Guidance for Industry issued on March 13, 2024.

May 13, 2024

CHPA acknowledges and supports FDA’s endeavors to modernize inspection and compliance strategies through the integration of Remote Regulatory Assessments (RRAs). This approach, when harmonized with other regulatory oversight tools, has the potential to contribute significantly to a more efficient, risk-based, and focused inspection system.

Mar 26, 2024

CHPA looks forward to working closely with FDA and other key stakeholders throughout the OMUFA reauthorization process as we work together to ensure the continued success of FDA’s OTC monograph program.

Oct 27, 2023

Pursuant to 16 C.F.R. § 1.31, through this petition, Petitioners respectfully request that FTC withdraw the notice of penalty offenses that were sent to nearly 700 companies.

Sep 15, 2023

CHPA strongly urges the Food and Drug Administration to deny the petition to repeal 21 CFR 73.575, which permits the use of TiO2 in food and dietary supplements. Based on extensive scientific research and regulatory evaluations, TiO2 is deemed safe for use as a food additive when consumed within established regulatory limits.

Aug 29, 2023

CHPA thanks FDA for providing a process to give feedback from industry leveraging science and risk-based approaches to appropriately identify, assess and control (where needed) NDSRIs and preventing unacceptable levels of nitrosamines in drug products.

Jul 3, 2023

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