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Improved Medicine Access: New Rules for Active Ingredients

This act changes how key drug components are defined, potentially affecting the approval process for new medications. The goal is to ensure citizens have access to safe and effective medicines by standardizing terminology in food and drug regulations.
Key points
The act changes the definition of a drug's "active ingredient" to "active moiety" in federal regulations.
This change aims to facilitate and accelerate the market introduction of new, safe, and effective medicines.
Standardizing terminology can help avoid misunderstandings and streamline drug regulatory processes.
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Additional Information
Protecting Access to Safe and Effective Medicines Act of 2021
Print number: HR 1857
Sponsor: Rep. Schrader, Kurt [D-OR-5]
Process start date: 2021-03-11