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August 5, 2022 Regulatory Affairs

FDA Publishes Complex Generics News Resource

Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring Americans have access to safe, effective, high-quality, and more affordable generic drugs.

Given FDA’s focus on regulatory and scientific initiatives to expand and strengthen this important area of our nation’s public health system, this page will be updated regularly with information about recent Agency actions related to complex generics, including:

  • notable approvals
  • guidance documents
  • research
  • events

Since these products are generally harder to develop, fewer exist, resulting in less market competition. This means that complex generics may be more expensive and less accessible to the patients who need them. Complex generics are a key component of FDA’s Drug Competition Action Plan, which aims to bring more drug competition to the market and address the high cost of medicines, and the Generic Drug User Fee Amendments, which include special provisions related to complex generics.

Complex Generics News Webpage

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