Sentence examples for the approval pathways from inspiring English sources

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.

Several provisions aim to smooth the approval pathway for high-priority treatments.

And after over five years of delay, the approval pathway is finally in place leading to new, competitively priced treatments like Zarxio.

In the EU, for example: To reduce product-to-product variations, the regulatory approval pathway for follow-on biological medicinal products (biosimilars) differs from the approval pathway for small-molecule follow-on products (generics).

Because biologics are more complex than small-molecule drugs and because biosimilars are similar but not identical to their reference products, regulatory authorities around the world have recognized the need for a unique approval pathway for biosimilars that is distinct from the approval pathway for generics and that addresses these differences 8– 10.

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.

When the ACA was enacted, the regulatory approval pathway for biosimilars was estimated to save American taxpayers $7 billion over 10 years.

Thus, the abbreviated approval pathway specified in Section 505 j) of the FD&C Act is not usually available for protein products.

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.