Sentence examples for approval pathways from inspiring English sources

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.

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.

These devices compare favorably with the EpiPen in size and ease-of-use, but no manufacturer has applied to bring them to the U.S. Despite recent attempts to "harmonize" the approval pathways between EU regulators and FDA, the path to U.S. approval for an approved EU device remains long, costly and uncertain.

The US Food and Drug Administration FDAA) has recently recognized the promise of these tools by providing new guidance for initial approval pathways in preclinical prevention trials [ 2].

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.

The shorter approval pathway requires companies to show a product is "substantially equivalent" to one already on the market and typically does not require human testing.

The Biologics Price Competition and Innovation Act created an abridged approval pathway for biosimilars.