WORLD OF GENERIC DRUGS MODULE

Communicating with ANDA Holders

There are many communication tools used in the review process:

• Acknowledgement of receipt letter that states the date of the application filing.
• A refuse to receive letter. If an application for an injectable drug is submitted and is missing the sterility section, FDA will not accept it. The agency informs the company of the deficiency and directs it to the appropriate regulations. The company can resubmit the application with the added section for FDA review and decision.
• Deficiency letters can be in the areas of bioequivalence and labeling. The company can resubmit the application showing FDA that it has addressed the deficiency and has confidence in the product.