Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were notifications sent out by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) to drug manufacturers alerting them to the approval prospects of their

drugs A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalat ...

under development. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under

Title 21 of the Code of Federal Regulations Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (O ...

, section 314.110. In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval.

Guidelines

Approvable letters were issued to applicants at the end of the FDA's review period to indicate that the application or abbreviated application is basically approvable providing certain issues are resolved. It was an indication that the application substantially met FDA requirements if specific conditions, such as labeling changes, are agreed to. The letter described what was required by the FDA. Applicants had 10 days after the date of the approvable letter to amend the application, notify of intent to file for an extension, withdraw the application, request a hearing or notify that they agreed to an extension.

References

Food and Drug Administration {{pharma-stub, date=September 2018