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
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.
Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.
We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.
Interested in gaining an industry edge? Let us help you stay up to date.
Gain an Industry Edge With Expertise From ProPharma Group
Get the latest insights and top tips from our experts, delivered right to your inbox.
Have a complex challenge?