The FDA has expanded its Competitive Generic Therapy (CGT) program, aimed at fostering greater competition within the generic drug market. This initiative is particularly significant as it addresses the barriers that have historically limited the availability of generic alternatives, ensuring that patients have access to more affordable medications.
The CGT program not only streamlines the approval process for certain generic drugs but also provides a platform for manufacturers to identify and address market gaps. By facilitating quicker approvals for products that meet specific criteria, the FDA is actively promoting a more dynamic market landscape. This move is expected to have substantial implications for pricing strategies and market entry for generic manufacturers, particularly in therapeutic areas where competition has been lacking.
