select an FDA Federal Register Notice with a docket that is open for public comment. The notice may be for a proposed rule, guidance document, or other proposed policy (e.g., strategic plan). compose a comment that is written on behalf of a stakeholder (e.g., regulated entity, patient/consumer organization, trade organization), and provide support or oppose the proposed rule or policy (or part of it). Tips for submitting effective comments can be found here: https://www.regulations.gov/document/FS-2018-0053-0007. All comments are expected to demonstrate a proficiency in research, analysis, and advocacy. Please research dockets open for public comment using Regulations.gov . example, (rule, guidance, notice)

The FDA Federal Register Notice with docket number FDA-2019-D-0068 is open for public comment regarding the guidance document titled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations." This guidance document outlines the FDA's recommendations for the development and approval of biosimilar therapeutic proteins, which are intended to be highly similar to an already approved biologic product.

• All comments are expected to demonstrate a proficiency in research, analysis, and advocacy.

• regulated entity, patient/consumer organization, trade organization), and provide support or oppose the proposed rule or policy.