Sentence examples for approval pathway from inspiring English sources
But the FDA does have a mechanism for dealing with this – all drugs approved under the Accelerated Approval pathway are subject to post-market surveillance, which includes reporting on the safety and efficacy of the drug once it goes to market.
As the President's Council of Advisors on Science and Technology (PCAST) has noted, this flexibility was critical to approving the first cancer and HIV/AIDS drugs quickly (these drugs were approved under the "Accelerated Approval" pathway, which explicitly allows the use of surrogate biomarkers).
Provisional evidence leading to a drug's approval may later be validated; for example, one FDA review showed that most anticancer drugs approved using the accelerated approval pathway are eventually confirmed as safe and effective on the basis of successful post-approval studies.
Thanks to the Affordable Care Act (ACA), a regulatory approval pathway was finally mandated in 2010 enabling the Food and Drug Administration FDAA) to approve biosimilars.
7 In 1992, Congress authorized the "accelerated approval" pathway, allowing drugs treating serious or life threatening illnesses to be approved on the basis of surrogate endpoints reasonably likely to predict patient benefit.
Due to the abbreviated approval pathway, rigorous pharmacovigilance must be in place once a biosimilar mAb is approved in order to ensure its long-term safety and efficacy.
Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources.
That is further complicated by the need to make some medicines available to patients at key times, using expedited drug approval pathways.
A concerted set of strategies should be implemented to streamline the development of useful combination products, including expedited approval pathways and increased investment in formulation studies.
The FDA's classification and premarket reviews of first generation engineered tissue products have demonstrated that it is actively engaged in developing rational product approval pathways for engineered tissue products.
His senior thesis examines the impact of new regulatory pathways, particularly accelerated approval pathways, on bringing novel therapies to market.
