CHPA understands the proposed framework in the notice is limited to prescription drugs. We have an interest in this subject, however, since we could foresee the policies described have utility for nonprescription drugs under new drug applications.
Herein, CHPA provides feedback on the Office of Environmental Health Hazard Assessment (OEHHA) proposal to modify Section 25821, subsections (a) and (c)(2), Level of Exposure to Chemicals Causing Reproductive Toxicity.
CHP Canada and CHPA respectfully submit this brief to the Office of Information and Regulatory Affairs within the Office of Management and Budget in response to the US-Canada Regulatory Cooperation Council Request for Information (83 FR 50689).
Herein CHPA provides feedback on FDA’s recent draft guidance document addressing the labeling of dietary supplements containing live microbials (also referred to as probiotics).
Herein, CHPA provides feedback on the Food and Drug Administration’s Nutrition Innovation Strategy, particularly as it relates to the agency’s development and implementation of a consumer education campaign.
The proper application/usage, scope, and cause for revisions of the <661> suite of chapters is not clear nor intuitive which is a concern given the potential impact.
CHPA members look forward to publication of the final guidance and the companion proposed rule. Together these regulatory documents will provide insights that sponsors can consider when designing research and development proposals for Rx to OTC switch programs.
Herein, CHPA provides feedback on the Agricultural Marketing Service (AMS) request for comments on a Proposed Rule to establish the national mandatory bioengineered food disclosure standard.
Restricting consumers’ ability to utilize their own FSAs and HSAs and other tax-preferred accounts impose an unfair cost increase on individuals and families at a time when many are struggling financially.
