FDA Publishes New Product-Specific Guidelines for Generic Drug Development

On Feb. 16 2023, FDA published a new set of product-specific guidance documents that provide recommendations for developing generic drugs and creates evidence to support abbreviated new drug application (ANDA) approvals, which helps to streamline generic product and ANDA assessment.

The FDA publishes PSGs to help facilitate generic drug competition, supporting greater access to safe, effective, and potentially lower-cost treatments. Additionally, improving access to high-quality, affordable medicines helps the agency’s mission to advance public health.

The recent group of 30 PSGs includes:

• 21 new and 9 revised PSGs
• 21 PSGs for products with no approved ANDAs, including 13 complex products
• 19 PSGs for complex products (14 new and 5 revised PSGs), and 13 new PSGs for complex products with no approved ANDAs
• PSGs for products used for treatment of Human Immunodeficiency Virus (HIV), achondroplasia, migraines, hypoglycemia, and other conditions.

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

The FDA also updated their “Upcoming Product-Specific Guidances for Generic Drug Product Development” website to include PSG revision categories and brief descriptions of the revisions that will help applicants in determining if a PSG revision may impact their generic drug development program.

Source: FDA