FDA Urges Sponsors to Minimize Design Changes in Generic Drug Delivery Products

Manufacturers seeking approval for generic versions of drug-device combination products, such as prefilled syringes and auto-injectors, should strongly consider minimizing the differences between the generic’s user interface and that of the reference product, FDA advised in new draft guidance.

For products that involve changes in design, the agency recommended analyses, study designs and acceptable sample sizes for comparison data to support an ANDA — to show the changes do not increase the rate of errors by users.

According to the FDA’s draft guidance, the agency may accept design differences if they are adequately analyzed and scientifically justified, and it will assess the need for additional data on a case-by-case basis. In general, the agency expects users to be able to use the generic product without additional training.