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.
New molecular entities approvals — January to August 2020
Certain drugs/biologics are classified as new molecular entities (NMEs) for purposes of FDA review. Many of these products contain active ingredients that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.
Empire reviews the FDA-approved NMEs on a regular basis. To facilitate the decision-making process, attached is a list of NMEs approved from January to August 2020, along with the FDA approval pathway utilized.
November 2020 Empire Provider News