Submissions

We applaud the intentions of the proposed rule to expand access to needed products for contraception. We note, however, that the proposed rule raises significant challenges that would need to be addressed.

CHPA members have been working diligently on assessing potential for nitrosamine formation from APIs used in OTC medicines.

CHPA supports well-tailored efforts to protect the sensitive personal data of U.S. persons, including efforts intended to protect and strengthen the national security of the United States.

CHPA supports FDA’s continued efforts to support medical device innovation by facilitating to the use of PCCPs for efficient Agency review of medical device modifications. When finalizing the Draft Guidance, CHPA strongly encourages FDA to provide further clarity regarding the content and process for PCCPs on several points.

CHPA supports the Agency’s directive to increase enrollment of participants from historically underrepresented populations in clinical trials to improve the strength and generalizability of the evidence to demonstrate safety and/or effectiveness of FDA-regulated medical products, but requests clarification on several points.

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Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products; Draft Guidance for Industry issued on March 13, 2024.

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.