An act to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity 2021

Law Healthcare & Pharma Law

Date: 10th Nov, 2024 Source: Congress.gov Country: USA Original Source

Brief

The Public Law 117–9 amends the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity. The changes redefine "active ingredient" to "active moiety," which is defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations. This change affects various sections of the act, including those related to drug approval, labeling, and safety testing.

This content is restricted.

Highlights content goes here...

This content is restricted.

Congress.gov

RADA.AI

Hello! I'm RADA.AI - Regulatory Analysis and Decision Assistance. Your Intelligent guide for compliance and decision-making. How can i assist you today?

Suggested

An act to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity 2021

Brief

Congress.gov

Form successfully submitted. One of our GRI rep will contact you shortly

Thanking You!

Enter your Email

Verify Email

Tell us more about yourself

Select your work area

Select your country

All set.

An act to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity 2021

Brief

Congress.gov

Form successfully submitted. One of our GRI rep will contact you shortly

Thanking You!

Enter your Email

Verify OTP

Enter your Email

Verify Email

Tell us more about yourself

Select your work area

Select your country

All set.