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This document contains comments from the Nonprescription Drug Manufacturers Association (NDMA) addressing the FDA's proposal to remove ephedrine from the OTC Monograph, arguing against its classification
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How to fill out NDMA Comments on FDA Proposed Amendment of the Final Monograph for OTC Bronchodilator Drug Products

01
Review the FDA's Proposed Amendment for OTC Bronchodilator Drug Products.
02
Gather relevant data and insights pertaining to the proposed changes.
03
Draft your comments, ensuring clarity and relevance to the proposed amendment.
04
Cite specific sections of the proposed amendment when possible to support your points.
05
Ensure your comments are concise and follow any specific formatting guidelines provided by the FDA.
06
Submit your comments through the designated FDA portal or method outlined in the announcement.
07
Keep a copy of your submission for your records.

Who needs NDMA Comments on FDA Proposed Amendment of the Final Monograph for OTC Bronchodilator Drug Products?

01
Pharmaceutical companies producing OTC bronchodilator products.
02
Healthcare professionals concerned with respiratory care.
03
Patients using OTC bronchodilator medications.
04
Regulatory affairs professionals monitoring drug product regulations.
05
Advocacy groups focused on respiratory health.
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NDMA Comments refer to feedback or input provided by the National Drug Manufacturers Association regarding the FDA's proposed amendments to the regulations governing over-the-counter bronchodilator products. These comments serve to address concerns, provide insights, and suggest improvements to the proposed changes.
All stakeholders, including pharmaceutical companies, manufacturers of OTC bronchodilators, healthcare professionals, and organizations representing consumer interests, are encouraged to file NDMA Comments to share their perspectives on the proposed amendments.
To fill out NDMA Comments, individuals or organizations should clearly state their name, contact information, and affiliation, followed by concise comments addressing the proposed amendments. Supporting data and references should be included where applicable to substantiate any claims or suggestions.
The purpose of NDMA Comments is to gather diverse opinions and expert insights which can influence the final decision-making process regarding the proposed amendments. They aim to ensure that the regulations are effective, safe, and beneficial for the public.
NDMA Comments should include the commenter’s identity, contact details, their specific concerns or suggestions regarding the proposed amendments, any relevant scientific data, and the rationale behind their comments, ensuring a comprehensive and constructive feedback.
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