The US Food and Drug Administration (FDA) has published two final guidances for generic drug sponsors that the agency says will streamline the premarket review and approval process.
On 24 January, FDA published two guidances as part of its Drug Competition Action Plan (DCAP). According to the agency, the objective is to streamline the generic drug review process without compromising regulatory rigor to help bring new generics to market and increase competition.
“An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines,” said FDA in a statement announcing the guidances…
