FDA approvals and expedited pathways used: new molecular entities
The FDA approves new drugs/biologics using various pathways of approval. Recent studies on the effectiveness of drugs/biologics going through these different FDA pathways illustrates the importance of clinicians being aware of the clinical data behind a drug or biologic approval in making informed decisions.
Here is a list of the approval pathways the FDA uses for drugs/biologics:
- Standard Review: The Standard Review process follows well-established paths to make sure drugs/biologics are safe and effective when they reach the public. From concept to approval and beyond, FDA performs these steps: reviews research data and information about drugs and biologics before they become available to the public, watches for problems once drugs and biologics are available to the public, monitors drug/biologic information and advertising, and protects drug/biologic quality. To learn more about the Standard Review process, go here.
- Fast Track: Fast Track is a process designed to facilitate the development and expedite the review of drugs/biologics to treat serious conditions and fill an unmet medical need. To learn more about the Fast Track process, go here.
- Priority Review: A Priority Review designation means FDA’s goal is to take action on an application within six months. To learn more about the Priority Review process, go here.
- Breakthrough Therapy: A process designed to expedite the development and review of drugs/biologics that may demonstrate substantial improvement over available therapy. To learn more about the Breakthrough Therapy process, click here.
- Orphan Review: Orphan Review is the evaluation and development of drugs/biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. To learn more about the Orphan Review process, click here.
- Accelerated Approval: These regulations allowed drugs/biologics for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. To learn more about the Accelerated Approval process, click here.
Please open the attached PDF titled “New molecular entities approvals. January to August 2020.pdf” to view new molecular entities approvals from January to August 2020.
November 2020 Anthem Provider News - Georgia