The Pathway to FDA Approval
How Veterinary Drugs Are Regulated in the U.S.
The drug approval process for a veterinary cell therapy in the United States is overseen by the Center for Veterinary Medicine (CVM), a division of the Food and Drug Administration (FDA) as with other regulated drugs. To bring a new animal drug to market, the drug Sponsor must demonstrate the drug’s safety, effectiveness, and manufacturing quality including data from laboratory, clinical, and field studies. The Sponsor and CVM work closely together during the process and all data is reviewed by CVM to ensure accurate labeling and that all requirements are met prior to approval. This is a long and tedious process.
What Is Conditional Approval?
An important step in the process for some drugs – particularly those intended to address serious or life-threatening conditions in animals for which few or no alternatives exist – is conditional approval. Under this pathway, the CVM may grant Conditional Approval after all aspects of safety and manufacturing quality are complete and with demonstration of reasonable expectation of effectiveness. This allows for early availability for patients with a serious or life-threatening disease ensuring safety and quality are met and allows 5 years for a full demonstration of effectiveness.
Why Conditional Approval Matters for FCGS
Refractory feline chronic gingivostomatitis (FCGS) is an example of a serious condition for which few alternative treatments exist that falls under a conditional approval pathway with FDA.
From Conditional to Full Approval
Once data have been generated, submitted and reviewed demonstrating substantial evidence of effectiveness, CVM may grant full approval of the drug. This could occur anytime during the 5-year conditional approval period.
Ensuring Long-Term Safety and Efficacy
As with other regulated drugs, FDA maintains oversight during and after approval. This rigorous process ensures that veterinary drugs are both safe and effective for their approved indications in animals per the label.
