Approvable letter

Approvable Letter is a formal document issued by regulatory authorities, such as the Food and Drug Administration (FDA), to a pharmaceutical company. The letter indicates that the agency has completed its review of the company's New Drug Application (NDA) or Biologics License Application (BLA) and that the application is approvable, pending the resolution of specific issues.

Overview

An approvable letter is not an approval. It is a communication from the FDA to the applicant stating that the agency is prepared to approve the application provided certain conditions are met. These conditions may include minor clarifications or additional analyses of existing data, but do not usually require new clinical trials.

Content of an Approvable Letter

The content of an approvable letter varies depending on the specific issues that need to be addressed. However, common elements include:

• A statement that the FDA has completed its review of the application.
• A list of specific issues that need to be resolved before approval can be granted.
• A request for additional information or clarification, if necessary.
• A statement that the FDA is prepared to approve the application if the issues are satisfactorily resolved.

Response to an Approvable Letter

Upon receipt of an approvable letter, the applicant has the opportunity to respond to the FDA's comments and provide the requested information. The FDA then reviews the response and, if satisfactory, issues an approval letter.

Impact of an Approvable Letter

The issuance of an approvable letter is a positive step towards the approval of a new drug or biologic. However, it does not guarantee approval. The applicant must satisfactorily address the issues raised in the letter before approval can be granted.

See also

• Complete response letter
• New Drug Application
• Biologics License Application
• Food and Drug Administration